BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3020016 · Received March 25, 2013

    Report

    Report Number
    2024168-2013-01700
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: SION BLUE. ABOVE RATED BURST PRESSURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DEFLATION ISSUE COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE DEVICE. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY, THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH NO TORTUOSITY, HEAVY CALCIFICATION AND CONCENTRIC. THE VESSEL DIAMETER WAS 4.5MM AND THE LESION LENGTH WAS 25MM. THE ACCESS SITE WAS VIA THE FEMORAL ARTERY. AFTER ROTATION ATHERECTOMY (ROTA) WAS PERFORMED, A 4.5X8MM NC TREK WAS ADVANCED TO THE TARGET LESION. DURING ADVANCEMENT THERE WERE SOME PLACES WHICH WERE DIFFICULT TO ADVANCE DUE TO THE CALCIFICATION, BUT IT WAS ABLE TO CROSS THE LESION FINALLY. THEN THE BALLOON WAS INFLATED FOUR TIMES, BUT AFTER THE FIFTH INFLATION, THE BALLOON DID NOT DEFLATE. THE BALLOON WAS INFLATED FIVE TIMES AND IT IS NOT KNOWN EACH INDIVIDUAL DILATING PRESSURE, BUT THE MAXIMUM DILATING PRESSURE WAS 23 ATMOSPHERES (ATM). THUS A PHYSICIAN TRIED TO DEFLATE THE BALLOON USING A SYRINGE BUT IT FAILED. THEN A PHYSICIAN CUT THE HYPOTUBE FOR DEFLATION, BUT IT MADE NO DIFFERENCE. FINALLY A NON-ABBOTT BALLOON CATHETER WAS ADVANCED SHORT OF THE NC TREK BALLOON AND PUSHED THE NC TREK BALLOON. WHILE PUSHING THE NC TREK BALLOON, IT DEFLATED, SO IT WAS ABLE TO BE REMOVED FROM THE ANATOMY. THE PHYSICIAN COMMENTED THAT HE FELT THE BALLOON DEFLATION WAS SLOWER THAN USUAL PRIOR TO THE EVENT. THEN VESSEL PERFORATION WAS CONFIRMED WITH ANGIOGRAPHY WHICH WAS TREATED WITH BALLOONING USING A 3.0X8MM NC TREK AND IT TOOK 90 MINUTES FOR HEMOSTASIS. A PHYSICIAN COMMENTED THAT IT IS DIFFICULT TO IDENTIFY IF THE VESSEL PERFORATION OCCURRED DUE TO THE NC TREK. THE EVENT CAUSED A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE; HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECTS DURING THE 90 MINUTES IT TOOK FOR HEMOSTASIS. THE PROCEDURE WAS FINISHED AFTER THE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121955 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2091161

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention CONCOMITANT MEDICAL DEVICES