| Device Problems
Arcing 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)
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An angiodynamics executive district sales manager reported an issue with an eximo atherectomy catheter.During a procedure, a 2.0mm catheter was unable to cross the stented bifurcation, with a spartacore wire and destination sheath.The doctor then opted to use a 1.5mm catheter at 50mj one time and 60mj 3 times.The total laser time was 5 minutes.When the catheter was pulled out of the patient, the silver blade tip was missing.The tip was in the patient, on the wire.The doctor placed a supera stent (2 total) to secure the tip against the wall of the sfa, where it will remain.The patient did not experience any adverse effects or harm as a result of this incident and the procedure was completed with a good result.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
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Returned for evaluation was an auryon catheter.The 1.5mm catheter arrived with tip/blade detached and not returned.The fibers at the tip were degraded/broken.No manufacturing non-conformances were observed during sample evaluation.The rfid tag of the 1.5mm catheter was read and the catheter working time was 37sec at 50mj/mm2 and 274sec at 60mj/mm2.Working time was slightly above 5min (5.2min) but with much longer time lasing with 60mj/mm2 then with 50mj/mm2.The customer's reported complaint description of 1.5mm catheter having tip detached and retained inside patient was confirmed.The catheter sample presented an expected appearance per event description.The distal tip/blade was detached from the catheter and was not returned; the fibers were degraded and broken.The working time of the catheter was 37sec at 50mj/mm2 and 274sec at 60mj/mm2.The fibers at the tip were degraded/broken and indicate that the catheter was working for an extended period of time at excessive energy, which is contrary to the ifu.Ifu cautions against lasing at the same location for more than 10 seconds, i.E.With no catheter advancement.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: instructions for use is provided with the catheter device and contain the following statements: warnings - pay careful attention while using the catheter, avoid excessive force and be on alert for any potential damage.Inadvertent movement of the catheter may result in patient injury.Always use fluoroscopic surveillance when advancing the auryon catheter inside the patient vasculature to avoid misplacement, dissection, or perforation.Auryon catheter insertion over the wire until laser activation: you may use any other gw to cross the lesion, but the final gw that auryon catheters will track over should be 300cm 0.014", and preferably stiff gws.Once this gw is angiographically verified to cross the lesion in the vessel's lumen, it is ready for auryon catheter insertion over the wire.Advancement of auryon catheter through the lesion: do not to exceed 10 seconds of lasing at the same location.If you experience any difficulty to advance the auryon catheter, immediately start self-count-down.Self-count-down should start the moment you experience non-advancement of the auryon catheter.When advancement resumes, you should stop self-count-down and resume it if additional non-advancements are experienced.If the auryon catheter cannot be advanced by the 10th second of laser activation, you should release the foot switch to stop the laser, retract the catheter approximately 3-4 mm, and try to advance again while rotating the catheter shaft approximately 90 degrees to either side, while resuming 10 seconds count down.If the auryon catheter is still not advancing with the above-mentioned rotation manipulation for the additional 10-seconds, immediately stop the laser activity by releasing the footswitch.Ask the laser operator to raise the fluence to the 60mj/mm2.Activate the laser and try again to advance the auryon catheter through the lesion.If the auryon catheter cannot be advanced, resume the self-count-down to 10 seconds.If the auryon catheter cannot be advanced in this attempt, stop the laser activity, withdraw the auryon catheter and use a new catheter a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
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