BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 5787459 · Received July 12, 2016

    Report

    Report Number
    2024168-2016-04520
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    January 13, 2016
    Report Date
    July 12, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    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 MEDICAL PRODUCTS: GUIDE WIRE: BALANCE HEAVYWEIGHT; OTHER: 6F GUIDELINER. A PARTIAL UNIQUE DEVICE IDENTIFIER (UDI) IS BEING REPORTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A CINE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST WHO NOTED A LARGE DISSECTION AFTER USE OF THE NC TREK FOR PRE-DILATATION. THE REPORTED PATIENT EFFECT OF INTIMAL DISSECTION IS LISTED IN THE CORONARY DILATATION CATHETERS (CDC), NC TREK RX, GLOBAL INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD). PREDILATATION WAS PERFORMED USING A 2.5X12MM TREK BALLOON CATHETER, A GUIDELINER 6F AND A 2.75X12MM NC TREK. TWO ABSORB SCAFFOLDS WERE IMPLANTED SUCCESSFULLY AT 11 ATMOSPHERES. POST-DILATATION WAS PERFORMED WITH A 2.75X12MM NC TREK BALLOON, 4 TIMES; HOWEVER, AFTERWARDS IT WAS NOTED THAT BOTH SCAFFOLDS HAD RECOILED. A 3.0X32MM NON-ABBOTT DRUG ELUTING STENT WAS IMPLANTED TO STABILIZE THE FRACTURED SCAFFOLDS. THE FINAL PATIENT OUTCOME WAS GOOD. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. CINE REVIEW IDENTIFIED THE VESSEL AS THE DISTAL MARGINAL BRANCH RATHER THAN THE LAD INITIALLY REPORTED. ADDITIONALLY, THE REVIEW NOTED A LARGE DISSECTION AFTER USE OF THE 2.75X12MM NC TREK FOR PRE-DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438206 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention