BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

    MDR report key: 1863537 · Received October 11, 2010

    Report

    Report Number
    3005099803-2010-04241
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K961345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION SHOWED RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. THE C-CLAMP WAS IN CLOSED POSITION. THE MEDICINE PORT WAS CLOSED, FEEDING PORT WAS OPEN. EXTERNAL BOLSTER WAS FOUND TO BE WITHOUT ISSUE. INTERNAL BOLSTER WAS MISSING FROM THE DEVICE AND WAS NOT RETURNED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BOLSTER DETACHED/SEPARATED. DURING THE PHYSICAL EVALUATION IT WAS FOUND THAT THE INTERNAL BOLSTER HAD BEEN SEPARATED AND DETACHED PORTION WAS NOT RETURNED. IT MOST LIKELY DETACHED DUE TO EXCESSIVE FORCE BEING USED DURING REMOVAL OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PERCUTANEOUS REPLACEMENT WAS USED DURING A REPLACEMENT, PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010, APPROXIMATELY THREE MONTHS AFTER THE DEPLOYMENT DATE, THE PHYSICIAN REMOVED THE DEVICE DUE TO SUSPECTED MOLD IN THE TUBE. THE DEVICE WAS NOT CULTURED TO VERIFY IT WAS MOLD. WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT'S STOMACH. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE INTERNAL BOLSTER. THE PHYSICIAN FELT THE FRAGMENT WOULD PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PERCUTANEOUS REPLACEMENT WAS USED DURING A REPLACEMENT, PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010, APPROXIMATELY THREE MONTHS AFTER THE DEPLOYMENT DATE, THE PHYSICIAN REMOVED THE DEVICE DUE TO SUSPECTED MOLD IN THE TUBE. THE DEVICE WAS NOT CULTURED TO VERIFY IT WAS MOLD. WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT'S STOMACH. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE INTERNAL BOLSTER. THE PHYSICIAN FELT THE FRAGMENT WOULD PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568151

    Patients

    Seq Age Sex Outcome Treatment
    1