BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2212351 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05758
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. ADDITIONALLY, IT WAS REPORTED THE CONTRAST WAS UNABLE TO BE INJECTED THROUGH THE LUMEN DURING THE PROCEDURE. IT IS POSSIBLE THAT THE BUILD UP OF BLOOD AND CONTRAST ON THE GUIDE WIRE AND INSIDE OF THE GUIDE WIRE LUMEN OF THE CATHETER CONTRIBUTED TO THE REPORTED DIFFICULTIES ADVANCING THE CATHETER OVER THE GUIDE WIRE AND THE CONTRAST UNABLE TO INJECT THROUGH; HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LOT NUMBER IS UNKNOWN BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALCOHOL ABLATION PROCEDURE FOR TREATMENT OF HYPERTROPHIC CARDIOMYOPATHY, A PROWATER GUIDE WIRE WAS ADVANCED IN THE SEPTAL PERFORATOR ARTERY FOLLOWED BY A 2.5 X 15 OTW TREK DILATATION CATHETER. RESISTANCE WAS FELT DURING ADVANCEMENT BETWEEN THE CATHETER AND THE GUIDE WIRE. THE CATHETER REACHED THE TARGET LOCATION AND THE BALLOON WAS INFLATED TO UNSPECIFIED ATMOSPHERES WITHOUT DIFFICULTY. THE PHYSICIAN ATTEMPTED TO INJECT ADDITIONAL CONTRAST; HOWEVER, CONTRAST WOULD NOT GO THROUGH WHILE THE BALLOON WAS INFLATED. THE PHYSICIAN EXPRESSED CONCERN THAT THE BALLOON MIGHT WATERMELON SEED (MOVE); THEREFORE, THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED FROM THE ANATOMY, OVER THE GUIDE WIRE, WITHOUT RESISTANCE. A NON-ABBOTT DILATATION CATHETER WAS ADVANCED OVER THE SAME GUIDE WIRE WITHOUT RESISTANCE AND DILATATION WAS PERFORMED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT; HOWEVER, THERE WAS A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE WIRE: PROWATER