BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1961937 · Received January 15, 2011

    Report

    Report Number
    2024168-2011-00313
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 VISIBLE ON THE SHAFT, BALLOON, AND HUB, WHICH IS CONSISTENT WITH THE CATHETER ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON WAS TIGHTLY FOLDED. THE CROSSING PROFILE AND 2/3 COLLAPSED BALLOON PROFILE WERE MEASURED AND MET MANUFACTURING CRITERIA. THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED 20.4CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE MATERIAL AT THE SEPARATION WAS STRETCHED. THERE WERE MULTIPLE BENDS NOTED TO THE HYPOTUBE. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, IT WAS REPORTED THAT FORCE WAS APPLIED TO THE CATHETER IN THE ATTEMPTS TO CROSS THE LESION AS RESISTANCE WAS ENCOUNTERED, WHICH LIKELY CONTRIBUTED TO THE SHAFT BENDING. FURTHER MANIPULATION OF THE SHAFT OUTSIDE OF THE PATIENT ANATOMY WOULD HAVE RESULTED IN THE SHAFT ULTIMATELY SEPARATING. 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. IT SHOULD BE NOTED THAT THE VOYAGER NC 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. DO NOT USE, OR ATTEMPT TO STRAIGHTEN, A CATHETER IF THE SHAFT HAS BECOME BENT OR KINKED; THIS MAY RESULT IN THE SHAFT BREAKING. INSTEAD, PREPARE A NEW CATHETER. THE REPORTED FAILURE TO ADVANCE AND SHAFT SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON FAILED TO CROSS A HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION. FORCE WAS APPLIED TO PUSH THE BALLOON, AND THE PROXIMAL PART OF THE SHAFT BECAME BENT. THE BALLOON WAS WITHDRAWN AND THE SHAFT WAS STRAIGHTENED OUT. IT WAS ATTEMPTED TO CROSS THE LESION AGAIN, DURING WHICH, THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THOUGH REQUESTED, 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 AV-TEMECULA-CT 0052061

    Patients

    Seq Age Sex Outcome Treatment
    1