BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPEEDTAC®

    MDR report key: 3944936 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02502
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MBI
    PMA / PMN Number
    K971139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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. VOLUNTARY USER MEDWATCH NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRCN SPD TAC DEVICE REVEALED THAT THE ANCHOR HAD DETACHED FROM THE SUTURE. THE RETURNED SUTURE HAD BEEN REMOVED FROM THE ANCHOR AND WAS UNBROKEN. THE ANCHOR HAD BEEN DETACHED FROM THE HANDLE AND WAS NOT RETURNED. 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. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED.  THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PRECISION SPEEDTAC WAS USED DURING A VAGINAL SLING AND ANTERIOR/POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE ANCHOR BROKE OFF FROM THE SUTURE DURING IMPLANTATION OF THE SLING. THE SUTURE WAS REMOVED FROM THE PATIENT, HOWEVER, THE ANCHOR WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRECISION SPEEDTAC. THE PATIENT WAS REPORTED TO BE STABLE AND IN GOOD CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PRECISION SPEEDTAC WAS USED DURING A VAGINAL SLING AND ANTERIOR/POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE ANCHOR BROKE OFF FROM THE SUTURE DURING IMPLANTATION OF THE SLING. THE SUTURE WAS REMOVED FROM THE PATIENT, HOWEVER, THE ANCHOR WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRECISION SPEEDTAC. THE PATIENT WAS REPORTED TO BE STABLE AND IN GOOD CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421346 PRECISION SPEEDTAC® FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BOSTON SCIENTIFIC - SPENCER M0068201450 16438585

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR