BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1891008 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02300
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BALLOON MATERIAL RUPTURE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIALS, HANDLING, LESION CHARACTERISTICS, PT DISEASE STATE, 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, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 90% 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. ULTIMATELY, RETURN OF THE VOYAGER MAY HAVE AIDED THE EVAL IN DETERMINING A CAUSE FOR THE RUPTURE. 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 MFG CRITERIA. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ECCENTRIC DE NOVO RIGHT CORONARY ARTERY (RCA), WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION, 90% STENOSIS, PRE-DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON CATHETER AT 14 ATMOSPHERE (ATM) AND A NON-ABBOTT STENT WAS DEPLOYED. POST-DILATATION WAS ATTEMPTED WITH THE 4.5 X 8 MM VOYAGER NC, BUT IT RUPTURED AT 10 ATM FOR 10 SECONDS DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED AND A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PT EFFECT. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9082861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 4.5 X 8 MM QUANTUM MAVERICK| GUIDE CATH: LAUNCHER 7F JR4| DILATATION CATHETER: 2.25 X 15 MM TAZUNA| STENT: 4.0 X 15 MM DRIVER SPRINT| GUIDE WIRE: RUNTHROUGH NS