BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPEEDTAC®

    MDR report key: 2250317 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03212
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MBI
    PMA / PMN Number
    K971139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE TWO RETURNED DEVICES REVEALED THAT THE ANCHORS WERE SECURELY COVERED WITHIN THEIR PROTECTIVE SHEATHS AND THE SUTURES WERE SEPARATED FROM THEIR RESPECTIVE ANCHOR ASSEMBLIES. THE SUTURES APPEARED TO UNBROKEN, HOWEVER ONE OF THE SUTURES HAD ONE END PINCHED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL SLING PROCEDURE USING A PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM, THE SUTURE WAS BROKEN WHEN IT WAS BEING REMOVED FROM ITS PACKAGING. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL SLING PROCEDURE USING A PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM, THE SUTURE WAS BROKEN WHEN IT WAS BEING REMOVED FROM ITS PACKAGING. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPEEDTAC® FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BOSTON SCIENTIFIC - SPENCER M0068201450 13625207

    Patients

    Seq Age Sex Outcome Treatment
    1