MARKED GUIDEWIRE (2/CS)

Additional Manufacturer Narrative

INVESTIGATION OF CUSTOMERS COMPLAINT IS INCONCLUSIVE. DEVICE USED IN PROCEDURE, IS NOT AVAILABLE FOR EVALUATION. NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE CANNOT BE VERIFIED, & ROOT CAUSE CANNOT BE IDENTIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED & FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED & FOUND NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 4 COMPLAINTS, REGARDING 4 DEVICES, FOR THIS DEVICE FAMILY & FAILURE MODE. DURING THIS SAME TIME FRAME 33,902 DEVICES HAVE BEEN MANUFACTURED & SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE & TAKING REMEDIAL ACTION. SINCE THE MARKED GUIDEWIRE IS A REUSABLE DEVICE THAT IS SUBJECTED TO VARIED USE & CLEANING ENVIRONMENTS, THE LIFE SPAN OF THE PRODUCT CANNOT BE GUARANTEED. LESS THAN 1PERCENT OF THE SPRING TIPS HAVE BEEN REPORTED TO HAVE BECOME DISLODGED DURING REUSE OR CLEANING. DISLODGEMENT OF SPRING TIP DURING USE MAY REQUIRE ENDOSCOPIC REMOVAL OF SPRING TIP. FAILURE TO REMOVE THE TIP MAY LEAD TO THE PERFORATION OF ESOPHAGUS, STOMACH OR BOWEL & THE CONSEQUENCES CUSTOMARILY ASSOCIATED THEREWITH. BEFORE & AFTER EACH USE, CAREFULLY INSPECT GUIDEWIRE FOR WEAR, DAMAGE OR ABNORMAL BENDING. ENTIRE WIRE SHOULD BE INSPECTED IN THIS MANNER, BUT AREAS OF EXTRA FOCUS INCLUDE FLEXIBLE SPRING TIP & SOLDERED JOINTS BETWEEN SPRING TIP & WIRE. IF THE JOINTS APPEAR DISCOLORED, LOOSE OR CRACKED, DISCARD THE GUIDEWIRE. IF WEAR, DAMAGE OR ABNORMAL BENDING IS FOUND AT ANY LOCATION ON GUIDEWIRE, DISCARD GUIDEWIRE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

ON 18OCTOBER2021, CONMED RECEIVED NOTIFICATION VIA FDA 3500A # (B)(4) OF REPORTED ISSUES WITH A MARKED SPRINGTIP GUIDEWIRE, ITEM 000150, LOT 202106164. INFORMATION ON THE 3500A INDICATES THE INCIDENT OCCURRED AT (B)(6) MEDICAL CENTER, ON (B)(6) 2021 AND INVOLVED A 67-YEAR-OLD PATIENT. THE 3500A REPORT ALSO INDICATES THE INCIDENT WAS A ¿PRODUCT PROBLEM¿ (NOT ADVERSE EVENT). THE INFORMATION NOTES ¿ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED. PATIENT WAS DILATED WITH A 48 FRENCH SAVORY. SURGEON REPORTED PERFORATION WHEN REASSESSING ESOPHAGUS. PROCEDURE WAS ABORTED. IT WAS FOUND THAT THE CLEANGUIDE DISPOSABLE. OTW ESOPHAGEAL DILATORS AND MARKED SPRINGTIP GUIDEWIRE KINKED DURING THE REMOVAL.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS IT IS NOTED THE PATIENT¿S ESOPHAGUS WAS PERFORATED.

Additional Manufacturer Narrative

AT TIME OF FILING, THE REPORTED DEVICE IS NOT EXPECTED TO BE RETURNED TO CONMED FOR EVALUATION. THIS REPORTED EVENT IS ENTERING THE INVESTIGATION PROCESS. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY

Description of Event or Problem

ON 18OCTOBER2021, CONMED RECEIVED NOTIFICATION VIA FDA 3500A # (B)(4) OF REPORTED ISSUES WITH A MARKED SPRINGTIP GUIDEWIRE, ITEM 000150, LOT 202106164. INFORMATION ON THE 3500A INDICATES THE INCIDENT OCCURRED AT (B)(6) MEDICAL CENTER, (B)(6), ON (B)(6) 2021 AND INVOLVED A (B)(6) PATIENT. THE 3500A REPORT ALSO INDICATES THE INCIDENT WAS A ¿PRODUCT PROBLEM¿ (NOT ADVERSE EVENT). THE INFORMATION NOTES ¿ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED. PATIENT WAS DILATED WITH A 48 FRENCH SAVORY. SURGEON REPORTED PERFORATION WHEN REASSESSING ESOPHAGUS. PROCEDURE WAS ABORTED. IT WAS FOUND THAT THE CLEANGUIDE DISPOSABLE. OTW ESOPHAGEAL DILATORS AND MARKED SPRINGTIP GUIDEWIRE KINKED DURING THE REMOVAL.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS IT IS NOTED THE PATIENT¿S ESOPHAGUS WAS PERFORATED.