BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1954398 · Received January 10, 2011

    Report

    Report Number
    3005099803-2010-05446
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    September 10, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE CARRIER IN THE EXTENDED POSITION, ENTERING IN THE CENTER SLOT AND WOULD NOT RETRACT UPON ACTUATION. THE EXTENDED BENT CARRIER INDICATED THAT THE CARRIER MAY HAVE BEEN STUCK DURING THE PROCEDURE WHEN THE WIRE FORM TO THE HYPO TUBE DETACHED. AN X-RAY EVALUATION REVEALED THAT THE WIRE FORM WAS DETACHED FROM THE FERRULE. NO WELDING DISCREPANCIES WERE NOTED, AND THE INVESTIGATION REVEALED NO ABNORMALITIES RELATED TO THE MATERIALS OF THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAULT SUSPENSION PROCEDURE USING A CAPIO OPEN ACCESS SUTURING DEVICE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY MAKE THE FIRST THROW. DURING THE SECOND THROW, THE CAPIO "NEEDLE DRIVER GOT STUCK" AND "IT DID NOT CATCH." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO OPEN ACCESS SUTURING DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAULT SUSPENSION PROCEDURE USING A CAPIO OPEN ACCESS SUTURING DEVICE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY MAKE THE FIRST THROW. DURING THE SECOND THROW, THE CAPIO "NEEDLE DRIVER GOT STUCK" AND "IT DID NOT CATCH." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO OPEN ACCESS SUTURING DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 13218349

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR