BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1944871 · Received January 3, 2011

    Report

    Report Number
    2024168-2011-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    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. DILATATION CATHETER: 4.0 X 12 MM POWERED LACROSS; STENT: 4.0 X 12 MM DRIVER. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS SUGGESTS THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 75% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. RETURN OF THE VOYAGER NC MAY HAVE FURTHER AIDED THE INVESTIGATION. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC MID RIGHT CORONARY ARTERY LESION, THE VOYAGER NC WAS USED FOR PRE-DILATATION; HOWEVER, DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 18 ATMOSPHERE (ATM). THERE WAS NO REPORTED PATIENT EFFECT. A NON-ABBOTT BALLOON WAS USED TO DEPLOY A NON-ABBOTT STENT TO COMPLETE THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 9062961

    Patients

    Seq Age Sex Outcome Treatment
    1