BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 10645895 · Received October 7, 2020

    Report

    Report Number
    2024168-2020-08363
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 17, 2020
    Report Date
    December 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648138447
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED MATERIAL SEPARATION WAS ABLE TO BE CONFIRMED. THE REPORTED DIFFICULT TO REMOVE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT DURING REMOVAL INTERACTION WITH THE HEAVILY CALCIFIED ANATOMY RESULTED IN THE REPORTED DIFFICULT TO REMOVE. MANIPULATION OF THE DEVICE RESULTED IN THE NOTED MULTIPLE DEVICE DAMAGES (BENT INNER MEMBER, KINKED INNER MEMBER/SKIVE, KINKED SUPPORT SKIVE/WIRE/BAYONET, MULTIPLE HYPOTUBE BENDS) AND ULTIMATELY RESULTED IN THE REPORTED MATERIAL SEPARATION. THE NOTED CHATTER MARKS ON THE OUTER MEMBER LIKELY RESULTED FROM INTERACTION WITH OTHER DEVICES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT FILED, USER FACILITY MEDWATCH REPORT (MW5097052) RECEIVED STATING: "SHAFT OF THE ABBOTT TREK BALLOON BROKE OFF IN PATIENT'S RIGHT LEG DURING ANGIOPLASTY PROCEDURE." THE FACILITY REPORTER WAS CONTACTED AND THE CORRECT DEVICE WAS CONFIRMED AS TREK CORONARY DILATATION CATHETER 1012274-20, LOT 90220G1.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A HEAVILY CALCIFIED, POPLITEAL TO FEMORAL BYPASS GRAFT. DIFFICULTY ACCESSING THE HEAVILY LESION SITE WAS OBSERVED. FOLLOWING, THE OPERATOR ADVANCED A TREK RX DILATATION CATHETER WITHOUT AN ADVANCEMENT ISSUE TO THE GRAFT SITE. SUCCESSFUL DILATATION WAS PERFORMED EIGHT TIMES. DURING DEVICE REMOVAL, RESISTANCE WAS THEN OBSERVED WITH THE TREK RX CATHETER DUE TO THE HEAVY CALCIFICATION AND THE TREK PROXIMAL SHAFT SEPARATED. A SNARE WAS UNSUCCESSFUL AT REMOVING THE SEPARATED PORTION. THE PATIENT WAS THEN TAKEN TO SURGERY AND AN OPEN SURGICAL CUT DOWN WAS PERFORMED, REMOVING THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA FOLLOWING. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS IN FINE AND STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106337 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012274-20 90220G1 08717648138447

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention