BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2252281 · Received September 17, 2011

    Report

    Report Number
    2024168-2011-06381
    Event Type
    Malfunction
    Date Received
    September 17, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: EVALUATION OF THE RETURNED NC TREK DILATATION CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN. THERE WAS BLOOD IN THE HUB. THE BALLOON WAS TIGHTLY FOLDED. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, IT WAS REPORTED THE LESION WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED WITH 90% STENOSIS, WHICH MAY HAVE CONTRIBUTED TO THE RESISTANCE. THE HYPOTUBE WAS SEPARATED AT THE DISTAL END OF THE HUB NOSEPIECE, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE HYPOTUBE CAN LEAD TO WEAKENING OF THE HYPOTUBE MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IN THIS CASE, IT IS LIKELY THAT AS RESISTANCE WAS MET DURING ADVANCEMENT IN THE LESION, THE HUB AND HYPOTUBE WERE INADVERTENTLY HANDLED RESULTING IN THE HYPOTUBE KINKING; THERE WAS NO DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTY. FURTHER MANIPULATION DURING THE SECOND ADVANCEMENT OF THE CATHETER LIKELY CONTRIBUTED TO THE HYPOTUBE SEPARATING. DURING FUNCTIONAL TESTING AN INDEFLATOR WAS ATTACHED TO THE HYPOTUBE, THE INDEFLATOR WAS FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER, AND WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP); THERE WAS NO DAMAGE NOTED TO THE BALLOON AND NO LEAK WAS NOTED. IT IS POSSIBLE THAT THE HYPOTUBE WAS ALREADY SEVERELY KINKED AT THIS POINT, RESULTING IN A PARTIAL SEPARATION WHICH WOULD CONTRIBUTE TO THE REPORTED AIR COMING INTO THE INDEFLATOR; HOWEVER THIS COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE PRE-DILATED, MILDLY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED MID CONCENTRIC LEFT ANTERIOR DESCENDING ARTERY LESION, THE 3.25 MM X 15 MM NC TREK WAS BEING ADVANCED BUT THE TIP WAS CAUGHT IN THE LESION AND STOPPED. THE NC TREK WAS REMOVED FROM THE ANATOMY. THE SAME 2.0 MM X 12 MM NON-ABBOTT PRE-DILATATION BALLOON CATHETER WAS ADVANCED TO THE LESION AS A SUPPORT DURING ADVANCEMENT OF THE NC TREK. THE SAME NC TREK WAS ADVANCED A SECOND TIME AND CROSSED THE TARGET LESION. THERE WERE TWO BALLOONS AND TWO GUIDE WIRES IN THE VESSEL AT THIS POINT. THE NON-ABBOTT BALLOON AND A GUIDE WIRE WERE REMOVED. AIR ASPIRATION WAS PERFORMED ON THE NC TREK HOWEVER, BLOOD AND AIR WAS NOTED COMING INTO THE INDEFLATOR. A LEAK WAS SUSPECTED AND THE BALLOON WAS NOT INFLATED IN THE LESION. DURING DEVICE REMOVAL FROM THE ANATOMY, THE HYPOTUBE DETACHED FROM THE INFLATION PORT AND THE INFLATION PORT WAS BENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A SECOND CORONARY DILATATION CATHETER WAS USED IN THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1030762

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION, GUIDE CATH: LAUNCHER 6F JL4.0