BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2003924 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01266
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER DILATATION CATHETER NOTED BLOOD VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN, CONSISTENT WITH A RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPTOUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 18 ATMOSPHERES (ATM) WHEN FLUID LEAKED OUT OF A PINHOLE IN THE BALLOON ABOVE THE DISTAL BALLOON MARKER. THERE WERE NO SCRATCHES FOUND AND IT COULD NOT BE DETERMINED IF THE PINHOLE WAS ALONG A CREASE OR FOLD. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LONGITUDINAL LEAK WAS LOCATED ON A CREASE OVER THE DISTAL MARKER. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH THE STENT OR OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE DEPLOYED STENT, OR THE HEAVILY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 10 ATM WHICH IS BELOW THE RBP. HOWEVER, THE EXACT CAUSE FOR THE PINHOLE TEAR WITHIN A BALLOON FOLD CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, A CONCLUSIVE CAUSE FOR THE REPORTED RUPTURE CANNOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS PREDILATED AND SUCCESSFULLY TREATED WITH THE DEPLOYMENT OF A XIENCE V STENT. THE VOYAGER BALLOON WAS BEING USED FOR POSTDILATATION; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES. POSTDILATATION WAS COMPLETED WITH A NON-ABBOTT BALLOON. NO PATIENT EFFECTS WERE REPORTED. 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 0081862

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR STENT: XIENCE V