VIEWFLEX XTRA ICE CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND THE CATHETER WAS DEFECTIVE UPON OPENING AS THE TIP WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE. ON 14-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER TIP WAS COMPLETELY SNAPPED AT THE CRYSTAL. THE AWARENESS DATE WAS RESET TO 14-DEC-2021, THE DATE INFORMATION WAS RECEIVED THAT A REPORTABLE EVENT OCCURRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE MANUFACTURE DATE AND EXPIRATION DATE WERE OBTAINED FOR THIS DEVICE ON 5-JAN-2022. THEREFORE SECTIONS D4 AND H4 HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER, AND THE CATHETER WAS DEFECTIVE UPON OPENING AS THE TIP WAS BROKEN. THE RETURNED DEVICE WAS RECEIVED COILED. THE DEVICE WAS CONFIRMED TO BE A RD087031 VIEWFLEX XTRA ICE CATHETER, CATHETER ID 00989520, REPROCESSED UNDER LOT 2163260 ON ITS FIRST REPROCESSING CYCLE. THE FIRST 2CM OF THE DEVICE WAS FRACTURED, BUT STILL ATTACHED TO THE SHAFT OF THE DEVICE WITH NO MATERIAL MISSING. THERE ARE ALSO KINKS AND BENDS IN THE LENGTH OF THE DEVICE. WHEN ACTUATED, DUE TO THE CUT ON THE SHAFT, THE TIP DOES NOT TURN WITH THE SHAFT AND THEREFORE THE DEVICE FAILED ITS MOBILITY TESTING. WHEN SUBJECTED TO ADDITIONAL ELECTRICAL FUNCTIONAL TESTING, THE DEVICE FAILED ITS TRANSDUCER TESTING, CONSISTING OF SENSITIVITY & CAPACITANCE TESTING ON THE FIRSTCALL 2000. RECORDS SHOW THAT THE DEVICE PASSED ITS FULL ELECTRICAL TESTING PRIOR TO BEING SHIPPED TO THE FIELD. THIS INDICATES THAT THE DAMAGE PRESENT ON THE TIP OF THE DEVICE AS WELL AS ITS COMPROMISED FUNCTIONAL PERFORMANCE, WAS NOT PRESENT PRIOR TO THE DEVICE BEING SHIPPED TO THE ACCOUNT, AND THAT IT HAS NO RELATION WITH CURRENT REPROCESSING METHODS. BASED ON THE OBSERVED DAMAGE AND PERFORMANCE ISSUES, THE COMPLAINT WAS CONFIRMED, HOWEVER THE ROOT CAUSE IS UNKNOWN. ADDITIONALLY, A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR LOT 2163260 AND NO INTERNAL ACTIONS WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4) IT IN THE INITIAL REPORT, IT WAS STATED THAT THE DEVICE WAS NOT RETURNED. THAT WAS INCORRECT. THE DEVICE WAS RECEIVED FOR ANALYSIS ON 22-DEC-2021. SECTION D9 WAS UPDATED.

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4). THIS IS A CORRECTION TO THE INITIAL REPORT H6 MEDICAL DEVICE PROBLEM CODE SHOULD BE A0401.