BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1033846 · Received April 24, 2008

    Report

    Report Number
    2024168-2008-00338
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND GUIDE WIRE LUMEN. THE BALLOON WAS SLIGHTLY PRESSURIZED. THE DISTAL BALLOON TAPER WAS BUNCHED. THERE WERE THREE KINKS IN THE HYPOTUBE, 5 CM, 61 CM, AND 112 CM DISTAL TO THE STRAIN RELIEF TUBING. THE OUTER MEMBER WAS NECKED FOR A LENGTH OF 1 MM AT THE PROXIMAL END OF THE BALLOON SEAL. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR, FILLED WITH RENOGRAFIN 60 DILUTED 1:1 WITH WATER, WAS USED TO PRESSURIZE BALLOON; HOWEVER, THE BALLOON WOULD NOT DEFLATE DUE TO THE NECKED OUTER MEMBER. PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: FAILURE TO DEFLATE MAY HAVE CONTRIBUTED TO DISSECTION WHICH REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: FAILURE TO DEFLATE. IT WAS REPORTED THAT A VOYAGER BALLOON CATHETER WAS POSITIONED AND INFLATED TO 10 ATM, HOWEVER, THE BALLOON COULD NOT BE SEEN. THE BALLOON WAS THEN DEFLATED AND RE-INFLATED TO 16 ATM AND THE BALLOON WAS STILL NOT VISIBLE. AS THE FLOW WAS LIMITED, IT WAS DECIDED TO WITHDRAW THE BALLOON CATHETER, WITH THE BALLOON STILL INFLATED. ANOTHER COMPANY'S BALLOON WAS ADVANCED. A DISSECTION WAS NOTED; HOWEVER, THE CAUSE OF THE DISSECTION IS UNKNOWN. ANOTHER COMPANY'S STENT WAS USED TO TREAT THE DISSECTION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY'S STENT BEING IMPLANTED AT THE LESION. REPORTEDLY, THE PATIENT WAS IN GOOD CONDITION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7112935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDE WIRE: WHISPER MS GUIDE WIRE| STENT: CYPHER