BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 8067205 · Received November 13, 2018

    Report

    Report Number
    2024168-2018-08769
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 13, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648138294
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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: SION, XT-R, CONQUEST PRO. GUIDE CATHETER: HYPERION. THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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 IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT WHEN THE BALLOON CATHETER WAS ADVANCED TOWARD THE LESION THE DEVICE MET RESISTANCE WITH THE MODERATELY CALCIFIED, 100% STENOSED, MILDLY TORTUOUS ANATOMY CAUSING THE REPORTED RESISTANCE DURING ADVANCEMENT, ULTIMATELY RESULTING IN THE BALLOON RUPTURE DURING INFLATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 100% STENOSED, CONCENTRIC LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. DURING ADVANCEMENT OF A 2.5X15 MM TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS FELT WITH THE LESION. THE BDC WAS INFLATED AND RUPTURED AT APPROXIMATELY 10 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT RESISTANCE AND A NON-ABBOTT BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906151 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80509G1 08717648138294

    Patients

    Seq Age Sex Outcome Treatment
    1