BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3250622 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04713
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RAMUS ARTERY. AFTER THE FIRST PRE-DILATION WITH A MINI TREK BALLOON DILATATION CATHETER (BDC), THEY UNSCREWED THE INDEFLATOR FROM THE HUB OF 1.5 X 15 MM MINI TREK BDC AND STARTED TO REMOVE THE BALLOON. THE GUIDING CATHETER AND FLOPPY GUIDE WIRE WERE LEFT INSIDE THE PATIENT. WITHOUT ANY EXTRA FORCE USED, THE HUB BROKE FROM THE SHAFT. A NON-ABBOTT BDC WAS USED FOR THE SUBSEQUENT DILATATIONS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350267 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30405G1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDE WIRE: HT FLOPPY