BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2964098 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00903
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. SEPARATION OF THE BALLOON AND CATHETER TIP WAS CONFIRMED. THE STRETCHING AND JAGGED FRACTURE FACE NOTED DURING RETURN GOODS ANALYSIS SUGGESTS EXCESSIVE FORCE WAS USED TO REMOVE THE FINISHED GOODS BALLOON SHEATH. 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 HAVE BEEN PUT IN PLACE TO PREVENT FURTHER RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND PRIOR TO USE, THE NC TREK BALLOON AND TIP WAS DETACHED FROM THE CATHETER INSIDE THE PACKAGING. IT WAS NOTED THE PROTECTIVE MANDREL WIRE AND THE CATHETER WERE PRESENT. THERE WAS NO PATIENT INVOLVEMENT. A SECOND NC TREK WAS USED IN 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
    68552 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2083162

    Patients

    Seq Age Sex Outcome Treatment
    1