BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1191225 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04912
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE CATHETER WAS BENT AT THE TIP AND ALONG THE ENTIRE LENGTH OF DEVICE. A FUNCTIONAL INSPECTION OF THE DEVICE REVEALED THAT THE NEEDLE DID NOT FULLY EXTEND AND RETRACT. THE DEVICE WAS DISASSEMBLED AND THE NEEDLE / HYPOTUBE ASSEMBLY WAS FOUND TO BE BENT. THE CAUSE OF THE REPORTED MALFUNCTION IS UNK. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS FOR ONE OF THE TWO REPORTED DEVICES, REFER TO MFR #3005099803-2008-04911 FOR THE OTHER REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "THE NEEDLE WOULD NOT COME OUT OR COME BACK." A SECOND INJECTION GOLD PROBE BIPOLAR CATHETER, WAS USED NAD THE COMPLAINANT ENCOUNTERED THE SAME PROBLEM. A DIFFERENT DEVICE (PLAIN INJECTOR NEEDLE) WAS USED TO COMPLETE THE CASE (MFR UNK) WITH NO COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11830354

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR