BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2134015 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04351
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 BALLOON CATHETER FOUND CONTRAST VISIBLE ON THE SHAFT AND IN THE LOOSELY-FOLDED, WHICH IS CONSISTENT WITH HANDLING AND SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE AND PRESSURIZED DURING THE PROCEDURE. THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON EXTENDING FROM THE DISTAL TAPER TO THE PROXIMAL SHOULDER. SCANNING ELECTRON MICROSCOPY (SEM) DETERMINED THAT THE BALLOON FAILURE MAY HAVE INITIATED FROM THE INSIDE OF THE BALLOON AT THE PROXIMAL MARKER. THERE WERE PARTIAL LONGITUDINAL TEARS OBSERVED ALONG THE INNER SURFACE ADJACENT TO THE FRACTURE. ADDITIONALLY, THE RUPTURE DID NOT APPEAR TO BE ALONG A FOLD CREASE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ALTHOUGH THE EXACT CAUSE FOR THE RUPTURE CANNOT BE DETERMINED, THIS TYPE OF DAMAGE IS MOST CONSISTENT WITH EXPOSURE CONDITIONS DURING THE PROCEDURE, A MATERIAL/PROCESSING DISCREPANCY, OR MULTIPLE INFLATIONS AND/OR HIGH STRESS BEING APPLIED TO THE BALLOON MATERIAL. THE LESION WAS ALSO CHARACTERIZED AS BEING NARROW WITH HEAVY TORTUOSITY AND CALCIFICATION, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, THE PROFILE DIMENSIONS ON ALL PRODUCTS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS. ALL DEVICES ARE ALSO 100% LEAK TESTED AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE (RBP) AND BALLOON INTEGRITY. DIFFICULTY CROSSING THE LESION/PHYSICAL RESISTANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, INTERACTIONS WITH OTHER DEVICES OR ACCESSORY DEVICE SUPPORT, AND IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN ADDITION, BALLOON MATERIAL RUPTURES MAY RESULT FROM FACTORS SUCH AS, BUT ARE NOT LIMITED TO: BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. 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 MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE ALSO DID NOT REVEAL ANY OTHER INCIDENTS REPORTED WITH THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT AND THE DEVICE ANALYSIS, THE REPORTED RESISTANCE/DIFFICULTY CROSSING THE LESION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A QUALITY DEFICIENCY ASSOCIATED WITH THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL RIGHT CORONARY ARTERY PROCEDURE, THE VOYAGER BALLOON CATHETER EXPERIENCED SIGNIFICANT RESISTANCE DURING INSERTION PRIOR TO A BALLOON RUPTURE AT 12 ATMOSPHERES. VESSEL AND LESION SITE WERE CHARACTERIZED AS BEING HEAVILY TORTUOUS AND CALCIFIED, CONCENTRIC AND NARROW. THE VASCULAR ACCESS SITE WAS RADIAL. ANOTHER OF THE SAME DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0043062

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR