VASCULAR LOOPS

Additional Manufacturer Narrative

THE VASCULAR LOOP SUBJECT OF THE REPORTED EVENT WAS DISPOSED OF AND COULD NOT BE RETURNED TO KEY SURGICAL FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE VASCULAR LOOP WAS MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. STATEMENTS FROM THE INSTRUCTIONS FOR USE INCLUDE, "CAUTION: PRIOR TO USE VISUALLY INSPECT PACKAGING. DO NOT USE IF DAMAGED, OPENED OR BREACHED AS STERILITY CANNOT BE GUARANTEED. INSTRUCTIONS FOR USE: 1. REMOVE VASCULAR LOOPS FROM POUCH. 2. REMOVE AND DISCARD CLIP. 3. VASCULAR LOOPS MAY BE SINGLE-OR DOUBLE-LOOPED AND CLAMPED AT THE SITE OR MAY BE CLAMPED TO VASCULAR SURGICAL DRAPES." KEY SURGICAL IS NOT THE MANUFACTURER OF THE RUMEL TOURNIQUET. STERIS NOTIFIED THE MANUFACTURER, BECTON DICKINSON, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED THAT IT DOES NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. KEY SURGICAL HAS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE VASCULAR LOOP; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT #4900240000-2023-8024 THAT WHEN THEY PUT THEIR RUMEL TOURNIQUET ON THEIR VASCULAR LOOP, THE VASCULAR LOOP BROKE. NO REPORT OF INJURY OR PROCEDURE DELAY.