BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2103474 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03716
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE SHAFT, CONSISTENT WITH HANDLING AND THE CATHETER AT LEAST PARTIALLY ADVANCED OVER THE GUIDE WIRE. THE BALLOON WAS TIGHTLY FOLDED. THE INNER DIAMETER OF THE GUIDE WIRE LUMEN WAS MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS A NEW GUIDE WIRE WAS BACKLOADED THROUGH THE RETURNED BALLOON CATHETER WITHOUT RESISTANCE NOTED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE 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. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION/REMOVE THE GUIDE WIRE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND CHECKED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RX TREK DILATATION CATHETER COULD NOT BE BACKLOADED ONTO THE WHISPER GUIDE WIRE. THE BACKLOADING STOPPED AT THE GUIDE WIRE EXIT NOTCH. DURING REMOVAL OF THE CATHETER FROM THE GUIDE WIRE, RESISTANCE WAS FELT; HOWEVER, ANOTHER RX TREK DILATATION CATHETER WAS LOADED ONTO THE SAME GUIDE WIRE SUCCESSFULLY. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1022162

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: WHISPER