BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMRX

    MDR report key: 1802646 · Received August 17, 2010

    Report

    Report Number
    3005099803-2010-03442
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, PATIENT AGE, DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. THE PATIENT IS OVER 18 YEARS OF AGE. (B)(4) - THE REPORTED EVENT OF DEVICE LEAKED AT THE C-CHANNEL. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE, THE DISTAL TIP WAS KINKED/DAMAGED AND THE RO MARKER WAS SLIGHTLY SHIFTED. A FUNCTIONAL EVALUATION FOUND THAT A LEAK WAS PRESENT AT THE BOND JOINT LOCATION OF THE DEVICE WHEN A GUIDEWIRE WAS ADVANCED/ PRESENT. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE LEAKED. DURING MANUFACTURING, DEVICES ARE 100% INSPECTED SO THE CONDITION FOR THE RETURNED IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX PRE-CURVED ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DEVICE WAS INSERTED INTO THE BILE DUCT AND LEAKAGE WAS NOTED AT THE C-CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; TIP DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMRX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - SPENCER M00545770 13229651

    Patients

    Seq Age Sex Outcome Treatment
    1