BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3771589 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02589
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. THE REPORTED DEFLATION ISSUE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT, FLOPPY TERUMO; GUIDE CATH: JR4 CORDIS; OTHER: VASCULAR SOLUTION GUIDING CATHETER EXTENSION, EXTERNAL PACEMAKER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, RESTENOSED LESION IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). AFTER IMPLANTING A 4X12 XIENCE XPEDITION STENT, THE 4.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION AND INFLATED IN THE PROXIMAL LESION; HOWEVER, THE BALLOON DID NOT DEFLATE. WHILE ATTEMPTING TO WITHDRAW THE BDC, RESISTANCE WAS FELT DUE TO THE BALLOON BEING INFLATED AND SUBSEQUENTLY THE HYPOTUBE BROKE INTO TWO PIECES. 30 CM OF THE DISTAL END OF THE BDC REMAINED IN THE ARTERY ALONG WITH THE INFLATED BALLOON. THE PATIENT WAS TRANSFERRED TO SURGERY FOR RETRIEVAL OF THE REMAINING PORTION OF THE BDC. THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS SHOWING GOOD RECOVERY IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250239 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31008G1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R