BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION®

    MDR report key: 2946373 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00402
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    September 25, 2012
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    MTD
    PMA / PMN Number
    K983171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: DURING THE AS RECEIVED VISUAL INSPECTION, DRIED BLOOD WAS PRESENT ON THE CATHETER. DURING THE VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE CATHETER'S SPLINE E RING ELECTRODE E2 WAS FOUND PARTIALLY PULLED UP/SHIFTED, AND STUCK TOWARDS THE DISTAL TIP. THE ELECTRICAL WIRE ON THE RING ELECTRODE E2 WAS FOUND POKING OUT ON THE SURFACE OF THE SPLINE TUBING. THE SPLINE E RING ELECTRODE E3 WAS FOUND PARTIALLY PULLED DOWN/SHIFTED, AND STUCK TOWARDS THE PROXIMAL END OF THE SPLINE TUBING, NEXT TO THE RING ELECTRODE E4. THE SPLINE E RING ELECTRODE E4 WAS ALSO FOUND PARTIALLY PULLED UP/SHIFTED, AND STUCK TOWARDS THE DISTAL TIP, NEXT TO THE RING ELECTRODE E3. THE SHRINK TUBING UNDERNEATH THE SPLINE G TUBING WAS FOUND TORN. THE CATHETER'S SPLINE F RING ELECTRODE E1 WAS FOUND PARTIALLY PULLED UP/SHIFTED TOWARDS THE DISTAL TIP, THE RING ELECTRODE E1 WAS FOUND FREE FLOATING. THE SPLINE F TUBING WAS FOUND STRETCHED AND PULLED UP AGAINST THE DISTAL TIP, THE STRETCHED TUBING STARTS FROM THE DISTAL END OF THE RING ELECTRODE E2. THE SPLINE TUBING F WAS ALSO FOUND TORN IN 3 DIFFERENT LOCATIONS. TWO OF THE TEARS WERE FOUND NEAR THE DISTAL END OF THE SPLINE TUBING, AND THE OTHER TEAR WAS FOUND AT THE TREADING AREA OF THE RING ELECTRODE ELECTRICAL WIRE. THE CATHETER'S SPLINE G RING ELECTRODE E1 AND E2 WERE FOUND PARTIALLY PULLED UP/SHIFTED, AND STUCK TOWARDS THE DISTAL TIP. THE RING ELECTRODE E1 WAS FOUND FLARED ON BOTH ENDS OF THE RING. THE SPLINE G TUBING WAS FOUND PARTIALLY STRETCHED AND PULLED UP TOWARDS THE DISTAL TIP. THE SPLINE G TUBING WAS FOUND TORN AT THE TREADING AREA OF THE RING ELECTRODE E1 ELECTRICAL WIRE. THE SHRINK TUBING UNDERNEATH THE SPLINE TUBING WAS ALSO FOUND STRETCHED TOWARDS THE DISTAL TIP, AND REMAINED BUNCH UP NEXT TO THE DISTAL TIP. ALL THE OTHER RING ELECTRODES OF THE SPLINES WERE FOUND INTACT AND IN PLACE. ALL THE OTHER SPLINE TUBING WERE ALSO FOUND INTACT AND NOT STRETCHED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. THE DFU STATES, "THE CONSTELLATION CATHETER IS INTENDED FOR USE ONLY WITH BOSTON SCIENTIFIC/EP TECHNOLOGIES 8.5F SOFT TIP SHEATH" AND ALSO THE CUSTOMER IS PRECAUTIONED, "DO NOT ADVANCE OR WITHDRAW THE CATHETER AGAINST EXCESSIVE RESISTANCE". (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY (EP) PROCEDURE, AN ELECTRODE BECAME LOOSE ON THE SPLINE. THE 48 UNIPOLAR CONSTELLATION WAS ADVANCED TO THE LEFT ATRIUM VIA A SL1 INTRODUCER SHEATH. IT WAS DETERMINED THAT ONE OF THE ELECTRODES BECAME LOOSE FROM ITS POSITION, HOWEVER, IT WAS FREE FLOATING AND CONTAINED ON THE SPLINE RATHER THAN BEING COMPLETELY DETACHED FROM THE CONSTELLATION CATHETER. THE CATHETER WAS REPLACED WITHOUT INCIDENT WITH ANOTHER OF THE SAME CATHETERS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PROTRUDING ELECTRODE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50838 CONSTELLATION® CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY MTD BOSTON SCIENTIFIC - SAN JOSE M004US8048U0 15078125

    Patients

    Seq Age Sex Outcome Treatment
    1