BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1937127 · Received December 23, 2010

    Report

    Report Number
    3005099803-2010-05241
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. NO INFORMATION AVAILABLE REGARDING WHETHER THE CAPIO CARRIER AND NEEDLES DETACHED INSIDE OR OUTSIDE THE PATIENT. (B)(4) - THE REPORTED ISSUES OF CARRIER AND NEEDLE DETACHMENT RESPECTIVELY.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE CAPIO OPEN ACCESS SUTURE CAPTURING DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2010-05239 AND 3005099803-2010-05240 PERTAIN TO THE OTHER TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE CAPIO CARRIER AND THE NEEDLES OF TWO 48" POLYPROPYLENE CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) DETACHED DURING SUTURING. "SEVERAL" ATTEMPTS TO SUTURE WERE MADE "BECAUSE NEEDLE WASN'T RETRIEVED AUTOMATICALLY BY CAPIO [DEVICE]." IT IS UNKNOWN IF THE CAPIO CARRIER AND NEEDLES DETACHED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITH "NO ACTION TAKEN BY THE PHYSICIAN TO RESOLVE THE EVENT." THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "STABLE" POST-PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 13133800

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other CAPIO DEVICES (BOSTON SCIENTIFIC)| CAPIO SUTURES (TELEFLEX MEDICAL)