PERL

Additional Manufacturer Narrative

LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

Description of Event or Problem

IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PERL PROCEDURE THE NEEDLE HOOK OF THE PERL DEVICE WAS RETAINED IN THE BREAST. THE WIRE WAS CLIPPED SHORTLY NEAR THE BASE OF THE SHARP CURVED PORTION. THE DISTAL PORTION WAS REMOVED DURING EXCISIONAL BIOPSY. PATIENT HAD ADDITIONAL IMAGING AND CONFIRMED THAT THE RETAINED PORTION WAS STILL IN THE BREAST. THE PATIENT IS SCHEDULED TO REMOVE SURGERY FOR REMOVAL OF THE RETAINED PART. NO OTHER INFORMATION IS AVAILABLE.