BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1841848 · Received September 21, 2010

    Report

    Report Number
    2024168-2010-01971
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 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 RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOUSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, 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 HEAVILY CALCIFIED AND 99% 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. THE BALLOON MATERIAL MAY HAVE BEEN DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. ULTIMATELY, RETURN OF THE RX VOYAGER MAY HAVE AIDED THE EVAL IN DETERMINING A CAUSE FOR THE EXPERIENCED 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. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. IN THIS INSTANCE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, HOWEVER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY, THE MERCURY BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE ANATOMY. AN RX VOYAGER DILATATION CATHETER WAS ADVANCED AND INFLATED TO 6 ATM; HOWEVER, A BALLOON RUPTURE OCCURRED DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE ANATOMY AND ATHERECTOMY WAS PERFORMED. A XIENCE V STENT WAS IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PT EFFECT. ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9100163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: BMW UNIVERSAL II| DILATATION CATHETER: MERCURY| STENT: XIENCE V| GUIDE CATH: LAUNCHER, ROTABLATOR