BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 4173661 · Received October 15, 2014

    Report

    Report Number
    3005099803-2014-03330
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED AND CATHETER WAS SLIGHTLY KINKED. EVIDENCE OF THE FLARE MANUFACTURING PROCESS WAS PRESENT ON THE CATHETER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT WAS CONFIRMED; THE FLARE DETACHMENT PREVENTED THE SNARE LOOP FROM EXTENDING. ADDITIONALLY, THE CATHETER WAS SLIGHTLY KINKED. HOWEVER, FLARE DETACHMENT IS CONTRARY TO WHAT WAS ORIGINALLY REPORTED. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE THE ROOT CAUSE OF THIS COMPLAINT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE ROTATABLE MEDIUM OVAL SNARES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-03331 ADDRESSES THE FIRST DEVICE AND MANUFACTURE REPORT # 3005099803-2014-03340 REFERENCES THE THIRD DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ROTATABLE MEDIUM OVAL SNARES WERE USED IN THE STOMACH DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCOPE WAS STRONGLY ANGLED WHEN AN ATTEMPT TO EXTEND THE FIRST SNARE WAS PERFORMED. IT WAS REPORTED THAT RESISTANCE WAS FELT DURING EXTENSION AND THE WIRE KINKED. A SECOND SNARE AND THIRD SNARE WERE USED, BUT THE SAME FAILURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A CAPTIVATOR SMALL HEXAGONAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. INVESTIGATION RESULTS REVEALED THE FLARE DETACHED, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653998 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 0017007687

    Patients

    Seq Age Sex Outcome Treatment
    1