MARKED GUIDEWIRE (2/CS)

Additional Manufacturer Narrative

PLEASE NOTE THIS REPORT IS BEING RESUBMITTED FOLLOWING AN UNSUCCESSFUL SUBMISSION ATTEMPT ON 25JUNE2021 DUE TO A SYSTEM ERROR. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED; THEREFORE, ROOT CAUSE CANNOT BE IDENTIFIED. A 2 YEAR LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE GUIDEWIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS MET WITHOUT DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION. BEFORE AND AFTER EACH USE, CAREFULLY INSPECT THE GUIDEWIRE FOR WEAR, DAMAGE OR ABNORMAL BENDING. THE ENTIRE WIRE SHOULD BE INSPECTED IN THIS MANNER, BUT AREAS OF EXTRA FOCUS INCLUDE THE FLEXIBLE SPRING TIP AND THE SOLDERED JOINTS BETWEEN THE SPRING TIP AND WIRE. IF THE JOINTS APPEAR DISCOLORED, LOOSE OR CRACKED, DISCARD THE GUIDEWIRE. IF WEAR, DAMAGE OR ABNORMAL BENDING IS FOUND AT ANY LOCATION ON THE GUIDEWIRE, DISCARD THE GUIDEWIRE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE 000150 DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2021 WHEN IT WAS REPORTED THAT ¿FLEXIBLE TIP BROKE OFF IN PATIENT¿ THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF INJURY/IMPACT TO THE PATIENT. THIS OCCURRED WHEN THE OPERATION WAS FINISHED AND THEY WERE REMOVING THE GUIDEWIRE. THE REPORTER STATED, ¿NOTHING HAPPENED, BUT SHE EMPHASIZED SOMETHING COULD HAVE BEEN SERIOUS.¿ A GOOD FAITH ATTEMPT WAS MADE TO ACQUIRE MORE INFORMATION, HOWEVER, TO DATE NO REPLY HAS BEEN RECEIVED. IF MORE INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REASSESSED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.