BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2080878 · Received May 7, 2011

    Report

    Report Number
    2024168-2011-03287
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    January 21, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE BALLOON, CONSISTENT WITH HANDLING. THE BALLOON WAS TIGHTLY FOLDED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE VOYAGER CATHETER WAS BEING USED IN THE HEAVILY TORTUOUS AND CALCIFIED TIBIAL ARTERY, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THE VOYAGER INSTRUCTIONS FOR USE (IFU) STATES: THE VOYAGER RX CORONARY DILATATION CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION OR BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE HYPOTUBE WAS SEPARATED 49 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE WAS OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS TORN AT THE SEPARATION AND HANGING BY A SMALL PIECE OF MATERIAL. THERE WERE TWO KINKS IN THE HYPOTUBE 1.8 CM DISTAL AND 2.3 CM PROXIMAL TO THE SEPARATION. 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 IS LIKELY THAT AS FORCE WAS APPLIED TO THE CATHETER AS RESISTANCE WAS ENCOUNTERED IN THE HIGHLY TORTUOUS AND CALCIFIED ANATOMY, THE SHAFT KINKED. NO DAMAGE WAS NOTED TO THE CATHETER DURING PREPARATION PRIOR TO USE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. FURTHER MANIPULATION OF THE SHAFT WOULD ULTIMATELY RESULT IN THE SHAFT SEPARATING. IT SHOULD BE NOTED THE IFU STATES: IF THERE IS RESISTANCE, 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 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 HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE FAILURE TO ADVANCE AND HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY TORTUOUS AND CALCIFIED TIBIAL ARTERY. WHILE TRYING TO PUSH THE 4.0 X 15 VOYAGER DILATATION CATHETER THROUGH THE EXTREMELY TIGHT LESION, THE SHAFT BROKE INTO TWO PIECES. THE CATHETER WAS REMOVED AND A 4.0 X 12 VOYAGER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 0060861

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR