BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2132491 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04290
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TREK BALLOON CATHETER WAS NOT RETURNED. A NON-ABBOTT BALLOON CATHETER WAS RETURNED WITH THE BALANCE MIDDLEWEIGHT GUIDE WIRE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO ISSUE WITH THE TREK BALLOON CATHETER, RATHER THE REPORTED RESISTANCE WAS WITH THE NON-ABBOTT BALLOON CATHETER. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE BALANCE MIDDLEWEIGHT GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH INFORMATION WAS RECEIVED CONFIRMING THAT THERE WAS NO ISSUE WITH THE TREK BALLOON CATHETER. THE RESISTANCE REPORTED WAS WITH A NON-ABBOTT BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON CATHETER WAS BEING USED WITH A BALANCE MIDDLEWEIGHT GUIDE WIRE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE TREK BALLOON WAS INFLATED ONE TIME AT 14 ATMOSPHERES FOR 20 SECONDS. AFTER BALLOON DEFLATION, DURING REMOVAL OF THE TREK BALLOON CATHETER, RESISTANCE WAS MET WITH THE GUIDE WIRE. THE BALLOON CATHETER AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT AND IT WAS NOTED THAT THE GUIDE WIRE TIP WAS DAMAGED BETWEEN THE SOFT AND RIGID SECTION. A NEW BALLOON CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1030261

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT