BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3812895 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01921
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF WORKING LENGTH DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE HAD A KINK IN THE CATHETER, AND A KINK IN THE WIRE NEAR THE HANDLE. THE FLARE WAS DETACHED FROM THE CATHETER IN THE PROXIMAL SECTION. THE CATHETER ALSO HAD MARKS FROM THE FLARE PROCESS. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT THAT THE SHEATH DETACHED WAS CONFIRMED. MANIPULATION OF THE DEVICE DURING PREPARATION LIKELY PRODUCED THE KINKS FOUND IN THE WIRE AND WORKING LENGTH, WHICH WOULD CREATE RESISTANCE DURING SUBSEQUENT ATTEMPTS TO ACTUATE THE DEVICE. ACTUATION AGAINST THIS RESISTANCE CAN ULTIMATELY CAUSE THE FLARE TO DETACH. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS HANDLING DAMAGE. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-01921, AND MANUFACTURER REPORT # 3005099803-2014-01922 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE MEDIUM OVAL SNARES WERE USED DURING A POLYPECTOMY PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SHEATH OF THE FIRST DEVICE DETACHED FROM THE HANDLE. WHILE PREPARING THE SECOND DEVICE THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-01921, AND MANUFACTURER REPORT # 3005099803-2014-01922 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE MEDIUM OVAL SNARES WERE USED DURING A POLYPECTOMY PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SHEATH OF THE FIRST DEVICE DETACHED FROM THE HANDLE. WHILE PREPARING THE SECOND DEVICE THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290746 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 16625150

    Patients

    Seq Age Sex Outcome Treatment
    1