BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1790273 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01630
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC BALLOON CATHETER NOTED THAT THE BALLOON WAS TIGHTLY FOLDED AND THERE WAS CONTRAST IN THE INFLATION LUMEN, SUGGESTING THAT THE CATHETER HAD BEEN PREPARED FOR USE. MEASUREMENTS OF THE TIP LENGTH, THE CROSSING PROFILE AND THE 2/3 BALLOON PROFILE WERE TAKEN AND ALL DIMENSIONS MET MANUFACTURING CRITERIA. OVERALL, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. FURTHERMORE, DIFFICULTY REMOVING THE CATHETER THROUGH THE GUIDING CATHETER MAY BE RELATED TO FACTORS INCLUDING, BUT NOT LIMITED TO, MFG, DAMAGE TO THE BALLOON, ANATOMICAL CONDITIONS, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. THE LESION WAS REPORTED AS HEAVILY CALCIFIED AND LIKELY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. THE ANALYSIS CONFIRMED THAT THE HYPOTUBE SHAFT, INCLUDING THE JACKET MATERIAL, WAS SEPARATED 21 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE ALSO MULTIPLE KINKS THROUGHOUT THE HYPOTUBE ADJACENT TO THE SEPARATION AND A KINK IN THE BAYONET PORTION. THE FRACTURE FACES OF THE SEPARATED HYPOTUBE WERE OVALED, INDICATING THAT THE SHAFT WAS BENT OR KINKED PRIOR TO FRACTURE. ADDITIONALLY, BOTH ENDS OF THE SEPARATED JACKET MATERIAL WERE JAGGED AND STRETCHED WHICH IS USUALLY A RESULT OF TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE CATHETER PRIOR TO THE PROCEDURE, THE SHAFT LIKELY BECAME DAMAGED DURING THE PROCEDURE OR AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. KINKS OR BENDS IN THE SHAFT CAN THEN LEAD TO WEAKENING OF THE SHAFT MATERIAL, SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING (KINKING, STRAIGHTENING, KINKING) CAN RESULT IN THE EVENTUAL FRACTURE OF THE HYPOTUBE. IN THIS CASE, IT IS LIKELY THAT THE CATHETER ENCOUNTERED RESISTANCE DURING AN ATTEMPT TO CROSS THE LESION, THE SHAFT MAY HAVE BENT/KINKED AND THEN SEPARATED UPON REMOVAL AS EXCESSIVE FORCE WAS APPLIED TO REMOVE THE DEVICE FROM THE ANATOMY. REPORTEDLY, THERE WERE MULTIPLE GUIDE WIRES AND A STENT WITHIN THE GUIDING CATHETER AT THE TIME OF THE PROCEDURE, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED RESISTANCE DURING ADVANCEMENT AND/OR RETRACTION OR THE DEVICE. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES: IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND/OR DAMAGE/SEPARATION OF THE CATHETER. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS INSTANCE, BASED ON THE INFO RECEIVED WITH THIS COMPLAINT AND THE RETURNED PRODUCT ANALYSIS, THE REPORTED FAILURE TO ADVANCE, DIFFICULTY TO REMOVE, SHAFT SEPARATION AND KINK DAMAGE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT DEFICIENCY. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS AT ABBOTT VASCULAR. ADDITIONALLY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED ONLINE FOR KINKS/DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY SHAFT INTEGRITY AND TENSILE STRENGTH.

    Description of Event or Problem · 1

    DEVICE ISSUE: PROXIMAL SHAFT SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE VOYAGER NC WAS UNABLE TO CROSS THE HEAVILY CALCIFIED DISTAL CIRCUMFLEX ARTERY. UPON REMOVAL OF THE VOYAGER NC FROM THE GUIDE CATH THAT ALSO CONTAINED THREE GUIDE WIRES AND A STENT, THERE WAS RESISTANCE FELT AND THE PHYSICIAN PULLED EXTREMELY HARD ON THE VOYAGER CAUSING THE PROXIMAL SHAFT TO BREAK NEAR THE HUB. THE BREAK OCCURRED OUTSIDE THE PATIENT AT THE LEVEL OF THE TUOHY VALVE. THE DISTAL SEGMENT OF THE VOYAGER NC WAS EASILY AND MANUALLY REMOVED FROM THE TUOHY VALVE. IT IS UNKNOWN IF ANOTHER DILATATION CATHETER WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0030561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRES: UNSPECIFIED| STENT: UNSPECIFIED