CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER,Īrcing at Paddles (1032) Loss of or Failure to Bond (1068) Break (1069) Failure to Charge (1085) Computer Software Problem (1112) Continuous Firing (1123) Crack (1135) Material Discolored (1170) No Display/Image (1183) Display or Visual Feedback Problem (1184) Failure to Deliver Energy (1211) Flaked (1246) Fluid/Blood Leak (1250) Fracture (1260) Material Fragmentation (1261) Material Frayed (1262) Labelling, Instructions for Use or Training Problem (1318) Inability to Irrigate (1337) Leak/Splash (1354) Mechanical Problem (1384) Melted (1385) Migration or Expulsion of Device (1395) Poor Quality Image (1408) Delivered as Unsterile Product (1421) Material Opacification (1426) Energy Output Problem (1431) Output above Specifications (1432) Pacing Problem (1439) Unsealed Device Packaging (1444) Pitted (1460) Failure to Power Up (1476) Off-Label Use (1494) Decreased Pump Speed (1500) Increased Pump Speed (1501) Failure to Pump (1502) Pumping Stopped (1503) Material Puncture/Hole (1504) Device Remains Activated (1525) Difficult to Remove (1528) Shipping Damage or Problem (1570) Stretched (1601) Inaccurate Synchronization (1609) Unexpected Therapeutic Results (1631) Use of Device Problem (1670) Insufficient Flow or Under Infusion (2182) Material Perforation (2205) Visual Prompts will not Clear (2281) Device Damaged Prior to Use (2284) Aborted Charge (2288) Arcing of Electrodes (2289) Incomplete or Missing Packaging (2312) Failure to Deliver (2338) Failure to Infuse (2340) Tear, Rip or Hole in Device Packaging (2385) Dull, Blunt (2407) Obstruction of Flow (2423) Failure to Calibrate (2440) Failure to Advance (2524) Misfire (2532) Arcing (2583) Delayed Charge Time (2586) Sparking (2595) Failure to Fire (2610) Battery Problem (2885) Calibration Problem (2890) Charging Problem (2892) Contamination /Decontamination Problem (2895) Communication or Transmission Problem (2896) Connection Problem (2900) Activation, Positioning or Separation Problem (2906) Detachment of Device or Device Component (2907) Device Markings/Labelling Problem (2911) Device Misassembled During Manufacturing /Shipping (2912) Device Sensing Problem (2917) Difficult to Advance (2920) Difficult to Open or Remove Packaging Material (2922) Expulsion (2933) Failure of Device to Self-Test (2937) Failure to Auto Stop (2938) Failure to Shut Off (2939) Infusion or Flow Problem (2964) Device Contaminated During Manufacture or Shipping (2969) Manufacturing, Packaging or Shipping Problem (2975) Material Deformation (2976) Material Integrity Problem (2978) Material Twisted/Bent (2981) No Flow (2991) Adverse Event Without Identified Device or Use Problem (2993) Output below Specifications (3004) Output Problem (3005) Packaging Problem (3007) Power Problem (3010) Pumping Problem (3016) Temperature Problem (3022) No Apparent Adverse Event (3189) Insufficient Information (3190) Appropriate Term/Code Not Available (3191) Device Handling Problem (3265) Wireless Communication Problem (3283) Migration (4003) Component Misassembled (4004) Material Too Soft/Flexible (4007) Firing Problem (4011) Complete Loss of Power (4015) Intermittent Loss of Power (4016) Unintended Electrical Shock (4018) Unexpected Shutdown (4019) No Visual Prompts/Feedback (4021) Intermittent Energy Output (4025)ĭevice Embedded In Tissue or Plaque (3165)Īn angiodynamics executive district sales manager reported an issue with an eximo atherectomy catheter.Ġmm catheter was unable to cross the stented bifurcation, with a spartacore wire and destination sheath.ĥmm catheter at 50mj one time and 60mj 3 times.
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