BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1884876 · Received October 15, 2010

    Report

    Report Number
    2024168-2010-02169
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ABBOTT VASCULAR-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH PREPARATION AND THE REPORTED ATTEMPT TO INFLATE THE BALLOON. A BMW GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST ON THE COILS. THERE WAS A BEND IN TIP 7.7 MM PROXIMAL TO THE TIPBALL. THERE WERE OFFSET AND OVERLAPPING INTERMEDIATE COILS 2 MM PROXIMAL TO THE CENTER SOLDER, FOR A LENGTH OF 4.5 MM. THE HYPOTUBE WAS SEPARATED AT THE DISTAL END OF THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED SHAPE AS IF KINKED PRIOR TO SEPARATION. THE JACKET WAS TORN AT THE SAME LOCATION, HANGING BY A THREAD. THE MATERIAL AT THE TEAR WAS STRETCHED AND JAGGED. THERE WERE MULTIPLE BENDS THROUGH OUT THE ENTIRE LENGTH OF THE HYPOTUBE DISTAL TO THE HYPOTUBE SEPARATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. A LUER WAS ATTACHED TO THE PROXIMAL END OF THE HYPOTUBE SEPARATION AND A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP). THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, BUT THE BALLOON WOULD NOT DEFLATE. THE INFLATION AND DEFLATION TIMES COULD NOT BE MEASURED DUE TO THE HYPOTUBE SEPARATION. THE JACKET SEPARATED DURING ANALYSIS. IN THIS CASE, IT IS LIKELY THAT THE SHAFT WAS INADVERTENTLY HANDLED RESULTING IN A KINK AND PARTIALLY SEPARATING THE HYPOTUBE, FURTHER CONTRIBUTING TO THE DIFFICULTIES INFLATING AND DEFLATING THE BALLOON. AND AS THE BALLOON WOULD ONLY PARTIALLY DEFLATE, THIS WOULD HAVE CONTRIBUTED TO THE DIFFICULTIES REMOVING THE CATHETER INTO THE GUIDE CATHETER. FURTHER MANIPULATION OF THE SHAFT LIKELY CONTRIBUTED TO THE SHAFT SEPARATING. IT WAS REPORTED THE PATIENT EXPERIENCED CHEST PAIN AND ST SEGMENT ELEVATION DURING THE PROCEDURE. ANGINA IS A KNOWN ADVERSE EVENT AS LISTED IN THE VOYAGER NC INSTRUCTIONS FOR USE (IFU). IN THIS CASE, IT IS POSSIBLE THAT THE FAILURE OF THE BALLOON TO DEFLATE CONTRIBUTED TO THE REPORTED ANGINA AND ST SEGMENT ELEVATION; HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS EVENT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED INFLATION/DEFLATION ISSUES, DIFFICULTY REMOVING THE CATHETER, AND NOTED HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROXIMATELY 2 YEARS POST XIENCE V STENT IMPLANTATION IN A RESTENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD), THE PATIENT HAD A POSITIVE STRESS TEST. STENOSIS WAS FOUND IN THE PLAD AND MID LAD. THE PLAD WAS TREATED WITH CUTTING BALLOON AND BALLOON ANGIOPLASTY AND THE MLAD WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THE PATIENT WAS INSTRUCTED TO CONTINUE MAXIMAL MEDICAL THERAPY AND WAS DISCHARGED ON THE SAME DAY IN STABLE CONDITION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF A XIENCE PRIME 3.5X12MM STENT, POST-DILATATION WAS PERFORMED WITH THE VOYAGER NC 4.0 X 8 MM. WHEN THE BALLOON WAS INFLATED TO 3 ATMOSPHERES IT WAS NOTED TO BE IRREGULAR, WITH CONTRAST VISIBLE IN PROXIMAL END ONLY, ALL FLOW OCCLUDED TO THE VESSEL. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON USING AN INDEFLATOR, BUT THE BALLOON WOULD NOT DEFLATE. THE PATIENT EXPERIENCED CHEST PAIN AND ST SEGMENT ELEVATION. AN ATTEMPT WAS THEN MADE TO DEFLATE THE BALLOON USING A 30CC SYRINGE, BUT IT STILL DID NOT DEFLATE. THE BALLOON WAS WITHDRAWN TO THE GUIDE CATHETER PARTIALLY INFLATED AND THE BALLOON, GUIDE WIRE AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THE TRANSIENT CHEST PAIN AND ST ELEVATION BOTH RESOLVED UPON REMOVAL OF THE BALLOON CATHETER. A NEW GUIDE CATHETER AND GUIDE WIRE WERE PLACED AND POST-DILATATION WAS COMPLETED WITH A VOYAGER NC 4.0 X 8MM WITH EXCELLENT ANGIOGRAPHIC RESULT. THE PATIENT WAS STABLE UPON COMPLETION OF CASE; NO CHEST PAIN OR ST ELEVATION POST PROCEDURE. 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 ABBOTT VASCULAR-TEMECULA NA 0050761

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: CORDIS XB3.5| INFLATION: BSC| GUIDE WIRE: BMW| STENT: XIENCE PRIME| SHEATH: CORDIS 6FR| RHV: AV| DIL CATH: VOYAGER NC