BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 5487838 · Received March 8, 2016

    Report

    Report Number
    2024168-2016-01418
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 8, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, GUIDE CATHETER: LAUNCHER 6FR JL. (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. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. 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 · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS NON-TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED. FOR PRE-DILATATION, A MINI TREK RX 2.0 X 15 MM BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND CROSSED. DURING THE SECOND INFLATION, THE PRESSURE OF THE INDEFLATOR DECREASED AT 10 ATMOSPHERES. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY, A BALLOON RUPTURE WAS NOTED. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143755 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50730G2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR