BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TRAVELER CORONARY DILATATION CATHETER

    MDR report key: 6118884 · Received November 21, 2016

    Report

    Report Number
    2024168-2016-08204
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 21, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648196348
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, GUIDE CATH: HYPERION 6F SPB3.5. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED MILDLY CALCIFIED, LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.75 X 15 MM NC TRAVELER BALLOON DILATATION CATHETER (BDC) WAS BEING INFLATED FOR PRE-DILATATION; HOWEVER, IT RUPTURED AT 15 ATMOSPHERES WHEN INFLATED FOR 30 SECONDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.75X15MM NON-ABBOTT BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769985 NC TRAVELER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40718G1 08717648196348

    Patients

    Seq Age Sex Outcome Treatment
    1