BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2014223 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01569
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION, USE IN THE ANATOMY AND RUPTURE. A NEW INDEFLATOR WAS USED IN THE ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED FROM A PINHOLE IN THE MIDDLE OF THE BALLOON. THERE WAS RANDOM PEELING ON THE FULL LENGTH OF THE BALLOON. THERE WERE NO SCRATCHES VISIBLE; THEREFORE, THE CATHETER WAS SENT TO SCANNING ELECTRON MICROSCOPY (SEM) FOR FURTHER ANALYSIS. THE ANALYSIS DETERMINED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. MECHANICAL DAMAGE WAS FOUND TO BE PRESENT AT THE EDGES OF THE LEAK AND SHREDDING WAS ALSO OBSERVED ALONG THE WORKING LENGTH, WHICH IS CONSISTENT WITH AN INTERACTION WITH THE LESION/ANATOMY. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. IT WAS REPORTED THAT NO LEAKS WERE NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WHICH MAY HAVE AIDED IN THE INVESTIGATION; HOWEVER IT WAS REPORTED THE VOYAGER BALLOON WAS INFLATED MULTIPLE TIMES WHICH SUGGESTS THE ANATOMY WAS DIFFICULT. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON AT 10 ATM AFTER MULTIPLE INFLATIONS, WHICH IS BELOW THE RATED BURST PRESSURE(RBP). 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 HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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 DURING PRE-DILATATION IN THE OBTUSE MARGINAL, THE VOYAGER BALLOON RUPTURED AT 12 ATMOSPHERES AFTER MULTIPLE INFLATIONS. ANOTHER 2.5 X 20 MM VOYAGER DILATATION CATHETER WAS USED SUCCESSFULLY TO PERFORM DILATATION. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0030561

    Patients

    Seq Age Sex Outcome Treatment
    1