BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1960984 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00284
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 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
    IL, US
    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 IN THE TIP AND ON THE SHAFT AND CONTRAST IN THE INFLATION LUMEN AND ON THE HYPOTUBE. THE BALLOON WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH USE OF THE PRODUCT. THE INNER MEMBER WAS SEPARATED 1CM DISTAL TO THE GUIDE WIRE EXIT NOTCH AND THE OUTER MEMBER SEPARATED 12.8CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. BOTH MATERIALS AT THE SEPARATION WERE JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE DISTAL PORTION OF THE SEPARATION INCLUDING THE BALLOON WAS FROZEN ON THE RETURNED GUIDE WIRE. THERE WAS 84CM OF THE RETURNED GUIDE WIRE PROTRUDING OUT FROM THE TIP OF THE RETURNED CATHETER. THERE WERE MULTIPLE KINKS IN THE OUTER MEMBER PROXIMAL TO THE SEPARATION, FOR A LENGTH OF 7.5CM. THE SHAFT WAS BUNCHED SPORADICALLY 6.3CM PROXIMAL TO THE PROXIMAL SEAL, FOR A LENGTH OF 8CM. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THE RETURNED GUIDE WIRE HAD BLOOD AND CONTRAST ON THE COILS AND CORE. THERE WERE THREE BENDS IN THE TIP PROXIMAL TO THE TIP BALL. THE SOLDER JOINTS AND OUTER DIAMETERS OF THE RETURNED GUIDE WIRE WERE MEASURED AND MET MANUFACTURING CRITERIA. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. IN THIS CASE, IT IS POSSIBLE THAT THE BUILD UP OF BLOOD IN THE GUIDE WIRE LUMEN OF THE CATHETER AND ON THE GUIDE WIRE CONTRIBUTED TO THE DIFFICULTIES ADVANCING THE CATHETER. ADDITIONALLY, AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE SHAFT BUNCHING, CREATING ADDITIONAL RESISTANCE. THE ATTEMPTS TO REMOVE THE FROZEN CATHETER FROM THE GUIDE WIRE WOULD THEN CONTRIBUTE TO THE SHAFT SEPARATION AND FURTHER DAMAGE TO THE CATHETER. A CONCLUSIVE CAUSE FOR THE DIFFICULTY ADVANCING/REMOVING THE CATHETER ON THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE SHAFT SEPARATION APPEARS 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 THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH DEVICES WERE USED WITHOUT ISSUE AND REMOVED FROM THE PATIENT. DURING PREPPING OF THE DEVICES, OUTSIDE OF THE ANATOMY, TO BE REINTRODUCED AND RE-USED IN THE PATIENT, ATTEMPTS WERE MADE TO BACKLOAD THE BALLOON AGAIN ONTO THE GUIDE WIRE. RESISTANCE WAS EXPERIENCED AND WHEN THE DEVICES WERE ATTEMPTED TO BE PULLED APART, THE SHAFT OF THE BALLOON SEPARATED. 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 0092862

    Patients

    Seq Age Sex Outcome Treatment
    1