BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2024112 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01825
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE LOOSELY-FOLDED BALLOON AND IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE WITHIN THE BODY. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. SCANNING ELECTRON MICROSCOPY ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK WAS CONFIRMED TO BE LOCATED ALONG A BALLOON FOLD/CREASE ON THE OUTER SURFACE. ADDITIONALLY, THERE WAS PEELING ON THE OUTER SURFACE AND DAMAGE OBSERVED ON THE INNER SURFACE ADJACENT TO THE LEAK. THE DISTAL BALLOON MARKER ALSO EXHIBITED A SLIGHT RIDGE IN THE MATERIAL. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING 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. A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD AND DAMAGE NOTED COULD NOT BE DETERMINED. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. REPORTEDLY, THE LESION WAS MILDLY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. NO PATIENT EFFECTS WERE REPORTED. ANOTHER BALLOON [UNSPECIFIED] WAS USED AND THE OUTCOME WAS VERY GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH, THE FOLLOWING INFORMATION WAS RECEIVED. THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0062261

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR