BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3120611 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03180
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS NOT CONFIRMED, HOWEVER, THE INNER MEMBER INSIDE THE BALLOON WAS SEPARATED AT THE PROXIMAL BALLOON MARKER AND THE SHAFT WAS STRETCHED/NECKED. THE SEPARATION OF THE INNER MEMBER AT THE PROXIMAL BALLOON MARKER WAS LIKELY MISTAKEN FOR THE REPORTED BALLOON RUPTURE. THIS DAMAGE ALONG WITH THE STRETCHED/NECKED PROXIMAL BALLOON SEAL LIKELY OCCURRED DURING THE REPORTED DIFFICULTY REMOVING THE SHEATH AGAINST RESISTANCE. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO RELATED NON-CONFORMANCE RECORDS FOR THIS SPECIFIC LOT. A QUERY OF THE COMPLAINT HANDLING SYSTEM WAS PERFORMED, REVEALING NO OTHER INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. AN EXPANDED RECORDS REVIEW WAS CONDUCTED AND FOUND A PRODUCT ISSUE POTENTIALLY RELATED TO DIFFICULTY REMOVING THE BALLOON SHEATH. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED AND CORRECTIVE AND PREVENTIVE ACTIONS ARE IN THE PROCESS OF BEING 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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE NON-TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY THE 3.5 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING PREPARED FOR USE BUT THE PROTECTIVE BALLOON SHEATH MET RESISTANCE AND COULD NOT BE REMOVED. FORCE WAS APPLIED AND THE PROTECTIVE SHEATH WAS SUCCESSFULLY REMOVED; THE NC TREK BDC WAS USED IN THE PROCEDURE. IT WAS NOTED THAT DURING THE FIRST INFLATION AT 10 ATMOSPHERE (ATM) THE BALLOON RUPTURED. A SECOND NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221430 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2021462

    Patients

    Seq Age Sex Outcome Treatment
    1