BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3890543 · Received June 24, 2014

    Report

    Report Number
    2024168-2014-04024
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCTS: GUIDE WIRE: BMW UNIVERSAL; GUIDE CATH: JR 4.0; STENT: 3.0X12 MM XIENCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE REPORTED PATIENT EFFECTS OF DISSECTION AND OCCLUSION, AS LISTED IN THE NC TREK RX CORONARY DILATATION CATHETER INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF THE DEVICE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 50% STENOSED, MID RIGHT CORONARY ARTERY. THE LESION WAS NEAR THE BIFURCATION OF THE ACUTE MARGINAL BRANCH (AM). PRE-DILATATION WAS PERFORMED ON THE LESION AND A 3.0X12 MM XIENCE STENT WAS DEPLOYED. POST-DILATATION OF THE IMPLANTED STENT WAS PERFORMED WITH THE 3.0X8 MM NC TREK BALLOON CATHETER. AFTER ONE INFLATION AT 12 ATMOSPHERES, THE BALLOON DEVELOPED A PIN-HOLE WHICH CAUSED A COMPLEX OCCLUSIVE DISSECTION PROXIMAL TO THE PLACED STENT. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER IN THE ANATOMY. SIX ADDITIONAL XIENCE STENTS (3.0X12 MM (X2), 3.0X33 MM; 2.5X18 MM; AND 2.25/18 MM (X2)) WERE DEPLOYED FOR TREATMENT RESTORING GOOD FLOW IN THE RCA. THE PATIENT HAD TO BE MOVED TO THE INTENSIVE CARE UNIT AND HAS SINCE BEEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367804 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31104G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention