BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ ANCHOR¿

    MDR report key: 6041336 · Received October 19, 2016

    Report

    Report Number
    2134265-2016-09760
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GBW
    PMA / PMN Number
    K811378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE SUTURE WAS BROKEN, AND ITS PROXIMAL SECTION WAS RIPPED/TORN. NO OTHER ANOMALIES OR DAMAGES. A MANDREL OF 0.038 INCHES WAS INSERTED THROUGH THE CATHETER AND PASSED PROPERLY WITHOUT RESISTANCE UPON FUNCTIONAL TESTING. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR¿ WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693279 AMPLATZ ANCHOR¿ CATHETER, PERITONEAL GBW BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001221000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention