BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION®

    MDR report key: 2980868 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01572
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    MTD
    PMA / PMN Number
    K983171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE REVEALED DURING THE VISUAL AND MICROSCOPIC INSPECTION, THAT ELECTRODE E1 OF SPLINE F WAS FOUND PARTIALLY PULLED UP/SHIFTED, AND STUCK TOWARDS THE DISTAL TIP. ELECTRODE E1 WAS DAMAGED AND AN UNKNOWN SMALL WHITE PLASTIC PIECE WAS FOUND LODGED BETWEEN THE ELECTRODE AND THE SPLINE TUBING. THE SPLINE F TUBING WAS ALSO FOUND STRETCHED AND REMAINED BUNCHED UP NEXT TO THE DISTAL TIP. THE STRETCHED TUBING IS VISIBLE STARTING FROM RING ELECTRODE E2. THE MARKER BAND FOR THE ELECTRODE E3 WAS FOUND FREE FLOATING ON THE SPLINE TUBING. STARTING FROM ELECTRODE E3, THE SPLINE TUBING IS AGAIN FOUND STRETCHED. ELECTRODE E1 ON SPLINE G WAS FOUND PARTIALLY PULLED UP/SHIFTED, AND STUCK TOWARDS THE DISTAL END OF THE SPLINE TUBING. THE MARKER BAND FOR THE ELECTRODE E2 WAS FOUND SLIGHTLY FLATTENED. ELECTRODE E3 ON SPLINE H WAS ALSO FOUND TO BE FLATTENED. 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 OR TORN. NEXT, AN INSERTION/WITHDRAWAL TEST WAS PERFORMED USING A KNOWN GOOD LAB 8.5 F SHEATH. THE CATHETER WAS SOAKED IN A (B)(4) WATER BATH FOR (B)(4). THEN THE 8.5F SHEATH WAS SUBMERGED IN THE (B)(4) BATH AND FLUSHED WITH SALINE DURING TESTING. THE CATHETER WAS INSERTED INTO AND WITHDRAWN 10 TIMES FROM THE 8.5F SHEATH. NO EXCESSIVE RESISTANCE WAS FELT DURING THE TEST. NEXT, THE ELECTRODE E1 ON SPLINE F WAS CUT TO REMOVE THE UNKNOWN WHITE PLASTIC. THE PLASTIC PIECE WAS FOUND TO NOT HAVE BEEN A PART OF THE CATHETER. NO SPLINE TUBING WAS FOUND MISSING, HOWEVER, THE TUBING WAS FOUND TORN IN TWO PLACES, UNDERNEATH WHERE THE WHITE PLASTIC PIECE WAS REMOVED. IT'S LIKELY THAT THE TEARS OCCURRED AS THE WHITE PLASTIC BECAME LODGED BETWEEN THE ELECTRODE AND THE TUBING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY (EP) PROCEDURE, A FILAMENT DETACHMENT OCCURRED. THE CONSTELLATION CATHETER WAS OBTAINING A MEASUREMENT IN THE RIGHT ATRIUM. AS THE CATHETER WAS BEING REMOVED FROM THE RIGHT ATRIUM, THERE WAS RESISTANCE BETWEEN THE SHEATH AND THE CONSTELLATION CATHETER. THE CATHETER WAS PUSHED FORWARD AND BACKWARDS IN THE SHEATH SEVERAL TIMES. THE CATHETER WAS ABLE TO BE PULLED BACK INTO THE SHEATH, ALONG WITH A PIECE OF LOOSE FILAMENT AND WAS REMOVED FROM THE BODY WITHOUT INCIDENT. THE PROCEDURE WAS CONCLUDED AT THIS POINT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY (EP) PROCEDURE, A FILAMENT DETACHMENT OCCURRED. THE CONSTELLATION CATHETER WAS OBTAINING A MEASUREMENT IN THE RIGHT ATRIUM. AS THE CATHETER WAS BEING REMOVED FROM THE RIGHT ATRIUM, THERE WAS RESISTANCE BETWEEN THE SHEATH AND THE CONSTELLATION CATHETER. THE CATHETER WAS PUSHED FORWARD AND BACKWARDS IN THE SHEATH SEVERAL TIMES. THE CATHETER WAS ABLE TO BE PULLED BACK INTO THE SHEATH, ALONG WITH A PIECE OF LOOSE FILAMENT AND WAS REMOVED FROM THE BODY WITHOUT INCIDENT. THE PROCEDURE WAS CONCLUDED AT THIS POINT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85035 CONSTELLATION® CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY MTD BOSTON SCIENTIFIC - SAN JOSE M004US8048U0 15695008

    Patients

    Seq Age Sex Outcome Treatment
    1 SJM SLO 8.5FR SHEATH