BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADICAL PROSTATECTOMY SUTURE CAPTURING DEVICE

    MDR report key: 2024209 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00804
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE NEEDLE CARRIER WAS BENT TO ONE SIDE. A FUNCTIONAL EVALUATION REVEALED THAT THE CARRIER DID NOT ALIGN WITH THE CENTER SLOT OF THE CAGE, AND THEREFORE THE CAGE FAILED TO CATCH THE NEEDLE OF THE SUTURE. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL ROOT CAUSE FOR THIS EVENT. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE WAS NOT PROVIDED, THE PATIENT IS REPORTEDLY OVER 18 YEARS OLD. (B)(4) - THE REPORTED EVENT OF "NEEDLE DETACHED". THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO RP SUTURE CAPTURING DEVICE WAS USED DURING A RADICAL PROSTATECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE NEEDLE OF THE CAPIO SUTURE (TYPE UNKNOWN) DETACHED INSIDE THE PATIENT'S URETHRAL SPHINCTER WHEN THE SUTURE WAS BEING THROWN THROUGH THE TISSUE. WHEN THE SUTURE WAS DEPLOYED, THE NEEDLE CARRIER WAS SLIGHTLY OFF CENTER AND DID NOT EXTEND INTO THE CENTER SLOT OF THE CAPIO DEVICE CAGE, SO THE CAGE DID NOT CATCH THE NEEDLE. WHEN THE PHYSICIAN RELEASED THE PLUNGER, THE SUTURE SLIPPED BACK INTO THE TISSUE, AT WHICH POINT THE NEEDLE DETACHED INSIDE THE PATIENT. IT IS UNKNOWN WHETHER ANY SUTURE WAS STILL ATTACHED TO THE NEEDLE OR IF THE DETACHMENT WAS A CLEAN BREAK. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT BECAUSE THE PHYSICIAN DETERMINED IT WOULD "CAUSE MORE DAMAGE" TO REMOVE IT THAN TO LEAVE IT IN. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO RP SUTURE CAPTURING DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY POSTOPERATIVELY BUT IT IS UNKNOWN WHETHER THE NEEDLE WAS VISIBLE. THE NEEDLE HAS NOT BEEN RETRIEVED FROM THE PATIENT SINCE THE INITIAL PROCEDURE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO RP SUTURE CAPTURING DEVICE WAS USED DURING A RADICAL PROSTATECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE NEEDLE OF THE CAPIO SUTURE (TYPE UNKNOWN) DETACHED INSIDE THE PATIENT'S URETHRAL SPHINCTER WHEN THE SUTURE WAS BEING THROWN THROUGH THE TISSUE. WHEN THE SUTURE WAS DEPLOYED, THE NEEDLE CARRIER WAS SLIGHTLY OFF CENTER AND DID NOT EXTEND INTO THE CENTER SLOT OF THE CAPIO DEVICE CAGE, SO THE CAGE DID NOT CATCH THE NEEDLE. WHEN THE PHYSICIAN RELEASED THE PLUNGER, THE SUTURE SLIPPED BACK INTO THE TISSUE, AT WHICH POINT THE NEEDLE DETACHED INSIDE THE PATIENT. IT IS UNKNOWN WHETHER ANY SUTURE WAS STILL ATTACHED TO THE NEEDLE OR IF THE DETACHMENT WAS A CLEAN BREAK. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT BECAUSE THE PHYSICIAN DETERMINED IT WOULD "CAUSE MORE DAMAGE" TO REMOVE IT THAN TO LEAVE IT IN. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO RP SUTURE CAPTURING DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY POSTOPERATIVELY BUT IT IS UNKNOWN WHETHER THE NEEDLE WAS VISIBLE. THE NEEDLE HAS NOT BEEN RETRIEVED FROM THE PATIENT SINCE THE INITIAL PROCEDURE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADICAL PROSTATECTOMY SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC - MIAMI M0068321010 13443501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CAPIO SUTURE (TYPE UNKNOWN)