BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANER ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 3464139 · Received October 7, 2013

    Report

    Report Number
    3003862657-2013-00005
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    September 4, 2013
    Report Date
    October 7, 2013
    Manufacturer
    REX MEDICAL L.P.
    Product Code
    MCW
    PMA / PMN Number
    K091029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: REVIEW OF CASE SUMMARY PROVIDED BY THE HOSPITAL; NO COMPLAINT SAMPLE RETURNED FOR EVALUATION; NO CASE IMAGES, VIDEOS, ETC WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED FOR REX FOR REVIEW. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED FOR THIS LOT NO. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE COULD NOT BE DETERMINED AT THIS TIME. CONCLUSION: THERE WAS NO COMPLAINT SAMPLE AVAILABLE FOR RETURN TO REX FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED TO SEE IF THERE WERE ANY ABNORMALITIES DURING THE MANUFACTURE OF THE LOT NUMBER IN QUESTION. NO ABNORMALITIES WERE DISCOVERED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS PRODUCT COMPLAINT.

    Description of Event or Problem · 1

    WRITTEN BY THE CUSTOMER: THE CASE WAS A LEFT FISTULA GRAFT THROMBECTOMY. WE USED THE CLEANER FOR THE THROMBECTOMY PORTION OF THE CASE. ONCE THAT PORTION OF THE CASE WAS COMPLETE AND UPON REMOVAL OF THE DEVICE, OUR PHYSICIAN NOTED THAT THE "WHITE END CAP" WAS MISSING. WE UTILIZED FLUORO TO SEE THAT THERE WAS, INDEED, A FOREIGN OBJECT THAT REMAINED IN THE PATIENT THAT WAS NOT PRESENT PRIOR TO USE OF THE DEVICE. AT THIS TIME WE ALSO NOTED SOME EXTRAVASATION. IT SEEMED THAT THE TIP HAD GONE OUT WITH THE EXTRAVASATION, EXTRAVASCULARLY AND WAS NO LONGER INSIDE THE VESSEL. THE DECISION WAS MADE TO BALLOON AND SEAL THE DAMAGED VESSEL AND LEAVE THE TIP WHERE IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507514 CLEANER ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL L.P. 700109 REF1300241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention