BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2091272 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03514
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 21, 2011
    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. GUIDE WIRE: HI-TORQUE WHISPER XTRA SUPPORT; GUIDE CATH: 6 FR CORDIS XP 3.5. THE WHISPER GUIDE WIRE IS BEING REPORTED UNDER A SEPARATE MFR NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER DILATATION CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE CATHETER ADVANCED OVER THE GUIDE WIRE. THE BALLOON WAS LOOSELY FOLDED. THE SOFT TIP, BALLOON, INNER MEMBER, AND OUTER MEMBER WERE BUNCHED CONFIRMING THE REPORTED INFORMATION. THE GUIDE WIRE USED DURING THE PROCEDURE WAS ALSO RETURNED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO 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. A MANDREL WAS ADVANCED THROUGH THE GUIDE WIRE EXIT NOTCH; HOWEVER, THE MANDREL DID NOT ADVANCE THROUGH THE BUNCHED DISTAL SHAFT. AN ATTEMPT WAS MADE BUT NEITHER THE RETURNED GUIDE WIRE OR A NEW GUIDE WIRE COULD BE ADVANCED THROUGH THE GUIDE WIRE LUMEN DUE TO THE BUNCHING. IT IS POSSIBLE THE COAGULATION OF BLOOD IN THE GUIDE WIRE LUMEN CONTRIBUTED TO CAUSING RESISTANCE REMOVING THE GUIDE WIRE. ADDITIONALLY, AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE TIP, SHAFT, AND BALLOON BUNCHING, WHICH WOULD FURTHER CONTRIBUTE TO THE RESISTANCE WITH THE GUIDE WIRE AS THERE WAS NO DAMAGE NOTED TO THE CATHETER PRIOR TO USE WHICH WOULD SUGGEST A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. 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 HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KISSING BALLOON TECHNIQUE OF THE OBTUSE MARGINAL AND CIRCUMFLEX ARTERIES, THE VOYAGER NC BALLOON CATHETER WAS SUCCESSFUL IN INFLATING AND FULLY DEFLATING; HOWEVER, THE BALLOON CATHETER COULD NOT BE RETRACTED FROM THE HI-TORQUE WHISPER GUIDE WIRE IN THE CIRCUMFLEX. AFTER MANIPULATION, THE BALLOON AND GUIDE WIRE WERE REMOVED AS A SYSTEM. OUTSIDE THE ANATOMY IT WAS NOTED THAT THE BALLOON AT THE TIP HAD ACCORDIONED [BUNCHED]. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A WHISPER XTRA SUPPORT GUIDE WIRE AND VOYAGER NC WERE USED TO COMPLETE THE CASE WITHOUT INCIDENT. THERE WAS NO ADDITIONAL INFORMATION 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 0042761

    Patients

    Seq Age Sex Outcome Treatment
    1