BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2944249 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00643
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 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 EVALUATION AND THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE, ADVANCE; GUIDE CATH: LAUNCHER 8FR JR4 SH . THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS, AND WAS AN IN-STENT RESTENOSIS (ISR) OF AN UNSPECIFIED NON-ABBOTT STENT. AFTER DILATATION WAS PERFORMED WITH A 2.0 X 8 MM TREK BALLOON CATHETER, THE 3.25 X 15 MM NC TREK BALLOON CATHETER WAS ADVANCED. THE NC TREK BALLOON WAS INFLATED TWICE AT 12 ATMOSPHERES (ATM), HOWEVER THE BALLOON RUPTURED AT 12 ATM DURING THE SECOND INFLATION. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR DURING REMOVAL OF THE DEVICE. A 3.5 X 15 MM NC TREK BALLOON CATHETER WAS USED FOR FURTHER DILATATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49201 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2060861

    Patients

    Seq Age Sex Outcome Treatment
    1