BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2993268 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01330
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, SEPARATION OF THE BALLOON WAS UNABLE TO BE CONFIRMED. IT SHOULD BE NOTED THAT PER THE NC TREK INSTRUCTIONS FOR USE, IN THE WARNINGS SECTION IT STATES THAT IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER. WHILE A SEARCH OF THE LOT HISTORY RECORD INDICATED NO RELATED NON-CONFORMANCE RECORDS FOR THIS SPECIFIC LOT, AN EXPANDED RELATED RECORD REVIEW AND INVESTIGATION WAS PERFORMED. A PRODUCT ISSUE POTENTIALLY RELATED TO DIFFICULTY REMOVING THE SHEATH WAS IDENTIFIED. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED AND CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN PUT IN PLACE TO PREVENT FURTHER RECURRENCE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): EXCESSIVE FORCE USED TO REMOVE PROTECTIVE SHEATH. THE CUSTOMER REPORTED THE DEVICE IS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION THE YELLOW PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE FROM OVER THE BALLOON. THE SHEATH WAS PULLED WITH FORCE, PULLING THE BALLOON OFF THE DILATATION CATHETER. THE DEVICE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. ANOTHER SIMILAR DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97029 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21013G2

    Patients

    Seq Age Sex Outcome Treatment
    1