BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3092285 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02751
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDING CATHETER: 6F MEDTRONIC LAUNCHER; INTRODUCER SHEATH: MEDTRONIC LAUNCHER. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE SHAFT SEPARATION WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN ADVANCING A 2.5X15 TREK RX BALLOON DILATATION CATHETER (BDC) INTO A 6F NON-ABBOTT GUIDING CATHETER, WITH THE TREK BALLOON APPROXIMATELY 10 CENTIMETERS INTO THE ANATOMY, RESISTANCE WAS FELT BETWEEN THE TREK AND THE INTRODUCER SHEATH, AND, THOUGH NO FORCE WAS APPLIED, THE BALLOON SHAFT FRACTURED APPROXIMATELY 10 CENTIMETERS PROXIMAL TO THE BALLOON (DISTAL SHAFT), THEN SEPARATED INTO TWO PIECES DURING WITHDRAWAL THROUGH THE GUIDING CATHETER, WITHOUT RESISTANCE FELT BETWEEN THE TREK AND GUIDING CATHETER OR BETWEEN THE TREK AND INTRODUCER SHEATH; THE SEPARATION SITE WAS OUTSIDE OF THE ANATOMY. THE BROKEN DISTAL PIECE WAS WITHDRAWN FROM THE ANATOMY SINCE THE SEPARATION SITE WAS OUTSIDE OF THE ANATOMY. ANOTHER TREK WAS USED WITH THE SAME INTRODUCER SHEATH, WITHOUT RESISTANCE, TO SUCCESSFULLY COMPLETE DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, WHILE THE 2.5X15 TREK RX BALLOON DILATATION CATHETER WAS REPORTED TO HAVE SEPARATED IN THE DISTAL SHAFT (AN AREA THAT IS INTRODUCED INTO PATIENT ANATOMY), THE RETURNED GOODS LAB RECEIVED THIS DEVICE WITH THE SEPARATION SITE NOTED TO BE LOCATED IN THE PROXIMAL SHAFT (AN AREA THAT IS NOT INTRODUCED INTO PATIENT ANATOMY). WHILE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SITE DID NOT RECALL THE EXACT LOCATION OF THE SEPARATION SITE, THE CORRECT DEVICE WAS CONFIRMED TO HAVE BEEN RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195123 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30108G1

    Patients

    Seq Age Sex Outcome Treatment
    1