BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1790259 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01624
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 12, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED CATHETER NOTED BLOOD VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. AN ATTEMPT WAS MADE TO INFLATE THE CATHETER WHEN FLUID WAS OBSERVED LEAKING OUT OF A RADIAL TEAR APPROXIMATELY 2 MM DISTAL TO PROXIMAL BALLOON MARKER, CONFIRMING THE REPORTED RUPTURE. ADDITIONALLY, THERE WAS A RADIAL SCRATCH ON THE OUTER SURFACE OF THE BALLOON ADJACENT TO THE RUPTURE SITE. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. 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. FURTHERMORE, EVIDENCE OF DAMAGE ON THE OUTER SURFACE OF THE BALLOON SUGGESTS THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE BALLOON. IN THIS CASE, THE PRESSURE AT WHICH THE BALLOON RUPTURED AT WAS NOT REPORTED, WHICH MAY HAVE FURTHER AIDED THE EVALUATION. HOWEVER, THE LESION WAS REPORTED AS HEAVILY CALCIFIED AND LIKELY CONTRIBUTED TO THE EXPERIENCED RUPTURE. IT IS POSSIBLE THAT AN INTERACTION WITH OTHER DEVICES AND/OR THE CALCIFIED LESION MAY HAVE DAMAGED (SCRATCHED) AND WEAKENED THE BALLOON MATERIAL, SUCH THAT THE BALLOON RUPTURED UPON INFLATION ATTEMPT. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, THE BALLOON RUPTURE AND MECHANICAL DAMAGE NOTED APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE PROFILE DIMENSIONS ON ALL PRODUCTS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS AT ABBOTT VASCULAR. ADDITIONALLY, ALL DILATATION CATHETERS ARE LEAK TESTED ONLINE AND A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE VOYAGER NC RUPTURED AT UNK PRESSURE IN AN UNSPECIFIED HARD CALCIFIED LESION. A SECOND VOYAGER NC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0051963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK