BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2881999 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08198
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: PROGRESS 40; GUIDE CATH: JR4; SHEATH: TERUMO 6 FR. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED LEAK DUE TO THE SEPARATION WAS CONFIRMED. BASED ON VISUAL 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 THE PATIENT WAS DIAGNOSED WITH A NEAR TOTAL OCCLUSION (95% STENOSIS) OF THE MID RIGHT CORONARY ARTERY (RCA) AND AN 80% STENOSIS OF THE LEFT ANTERIOR DESCENDING ARTERY. A PROGRESS 40 GUIDE WIRE CROSSED THE LESION, FOLLOWED BY PREDILATATION WITH A 1.2X12 MM MINI TREK BALLOON. THE PATIENT COUGHED WHILE THE DEVICES WERE IN THE ANATOMY CAUSING THE GUIDING CATHETER, GUIDE WIRE AND DILATATION BALLOON TO BACK OUT OF THE RCA. AFTER LETTING THE PATIENT REST FOR A WHILE, THE SAME GUIDE WIRE AND MINI TREK BALLOON WERE USED IN THE VESSEL; HOWEVER, THIS TIME THE MINI TREK BALLOON COULD NOT BE INFLATED. AFTER RETRACTION OF THE BALLOON CATHETER FROM THE PATIENT, THE BALLOON WAS FOUND TO BE SEPARATED AT THE HUB. THE PROCEDURE CONTINUED ON WITH ANOTHER BALLOON CATHETER AND A MULTI-LINK 8 STENT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PROCEDURE LASTED FOR APPROXIMATELY 2 1/2 HOURS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2042761

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR CONCOMITANT MEDICAL DEVICES