BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 3173428 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03776
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND ANALYZED. THE REPORTED BALLOON RUPTURE COULD NOT BE CONFIRMED ON THE RETURNED DEVICE. THE REPORTED PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A PROXIMAL SHAFT SEPARATION WAS OBSERVED, WHICH WAS MOST LIKELY DUE TO HANDLING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED AND THE ANALYSIS OF THE RETURN, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (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 THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOSITY, MILDLY CALCIFIED, 90% STENOSIS IN THE DISTAL CORONARY ARTERY. THE 4.5X12 MM VOYAGER NC BALLOON CATHETER WAS ADVANCED PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 18 ATMOSPHERES. A VOYAGER NC WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE. IT IS STATED THAT THERE WAS RESISTANCE DURING ADVANCEMENT OR RETRACTION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274118 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2040561

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR