BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2922946 · Received January 18, 2013

    Report

    Report Number
    2024168-2013-00337
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. IT SHOULD BE NOTED THAT THE RX TREK INSTRUCTION FOR USE STATES: DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED UNDER VACUUM. THE TECHNIQUE OF PULLING THE INFLATED BALLOON TO SUCK THE GUIDING CATHETER DOWN INTO THE ARTERY LIKELY CONTRIBUTED TO THE STRETCHING AND SEPARATION OF THE BALLOON MATERIAL. THE ADDITIONAL RX TREKS ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX ARTERY. THE 3.0 X 15 MM TREK BALLOON CATHETER WAS INFLATED TO 12 ATMOSPHERES (ATM). THE GUIDING CATHETER WAS ADVANCED THROUGH THE LEFT MAIN AND INTO THE CIRCUMFLEX. WHILE THE BALLOON WAS INFLATED, THE PHYSICIAN ATTEMPTED TO PULL BACK THE INFLATED TREK BALLOON TO SUCK THE GUIDING CATHETER DOWN INTO THE ARTERY; HOWEVER, THE BALLOON RUPTURED. A 3.5 X 12 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED, BUT COULD NOT CROSS TO THE LESION. A NEW TREK BALLOON WAS ADVANCED AND INFLATED TO 12 ATM; HOWEVER, THE BALLOON RUPTURED AGAIN. ANOTHER NON-ABBOTT SDS WAS ATTEMPTED, BUT WAS UNABLE TO ADVANCE INTO CIRCUMFLEX ARTERY. A THIRD 3.5 X 20 MM TREK BALLOON WAS ADVANCED AND INFLATED TO 12 ATM, AND THE GUIDING CATHETER WAS ATTEMPTED TO BE ADVANCED. THE PHYSICIAN CONTINUED TO MOVE THE BALLOON WHILE INFLATED, TO HELP PUSH THE GUIDING CATHETER DOWN. IT WAS THEN DISCOVERED THE TREK BALLOON WOULD NOT DEFLATE. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON WITHOUT SUCCESS. THE DISTAL PORTION OF BALLOON THEN SEPARATED IN THE ANATOMY. AN ATTEMPT WAS MADE TO SNARE THE BALLOON WITHOUT SUCCESS; THEREFORE, THE BALLOON PORTION WAS LEFT IN THE PATIENT, UNTREATED. THE PATIENT LATER PRESENTED AT ANOTHER FACILITY ON (B)(6) 2012 WITH CHEST PAIN. SURGERY WAS PERFORMED AND THE BALLOON PORTION WAS REMOVED. THE ACCOUNT BELIEVES THAT THE ISSUES WERE DUE TO THE TECHNIQUE AND NOT DUE TO THE DEVICES. THE PATIENT HAD A GOOD OUTCOME AND WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28232 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2011361

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R