BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 1989381 · Received February 14, 2011

    Report

    Report Number
    2024168-2011-00906
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. DILATATION CATHETER: 1.50 MM X 15 MM TREK (PART 1012405-20, LOT 0090961). GUIDE WIRE: WHISPER J. GUIDE CATHETER: 6 FR AL1. STENT: 3.0 MM X 28 MM XIENCE V. OTHER: PRONTO ASPIRATION CATHETER. THE DEVICE WAS NOT RETURNED. POTENTIAL FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY INFLATING AND/OR WATERMELON SEEDING MAY INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, DEVICE SIZE SELECTION, PLACEMENT OF THE BALLOON WITHIN THE LESION, OR PHYSICIAN TECHNIQUE. REPORTEDLY, THE MINI TREK WAS USED IN A TOTALLY OCCLUDED GRAFT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED WATERMELON SEEDING. REPORTEDLY, THE OTW MINI TREK WAS INFLATED TO 15 ATMOSPHERE (ATM) AND 16 ATM, WHICH IS ABOVE THE RATED BURST PRESSURE (RBP). IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE RBP IS BASED ON RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RBP. USE OF A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL DILATATION CATHETERS ARE SUBJECTED TO A 100% VISUAL INSPECTION. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A TOTALLY OCCLUDED GRAFT WITH THROMBUS TO THE CIRCUMFLEX MARGINAL, THE 1.5 MM X 15 MM TREK WAS USED TO PRE DILATATE THE LESION AT 15 ATMOSPHERE (ATM) AND 16 ATM. THERE WAS NO REPORTED PATIENT EFFECT. A SECOND 2.5 MM X 20 MM TREK WAS USED TO RECROSS THE LESION AND WAS INFLATED 3 SEPARATE TIMES AT 10 ATM. IT WAS NOTED THAT THE BALLOON WATERMELON SEEDED AND MOVED IN THE FIBROTIC PLAQUE. THERE WAS NO REPORTED PATIENT EFFECT. THOUGH REQUESTED, 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 0081961

    Patients

    Seq Age Sex Outcome Treatment
    1