BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN EMBOLECTOMY CATHETER

    MDR report key: 754114 · Received November 7, 2005

    Report

    Report Number
    1220948-2005-00004
    Event Type
    Malfunction
    Date Received
    November 7, 2005
    Date of Event
    January 4, 2005
    Report Date
    November 4, 2005
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY AND CONCLUSION: SURGEON THAT COMPLETED THE PROCEDURE, WAS CONTACTED FOR FURTHER INFORMATION. HE SAID THE VESSEL WAS NOT TORTUROUS, BUT THE CATHETER WAS USED IN THE AV-GRAFT ANASTOMOSIS AREA WHERE A HIGH-GRADE STENOSIS WAS SITUATED. THE CATHETER WAS STUCK IN THE STENOTIC AREA AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE CATHETER. THE TIPS BREAKING OFF THE CATHETER WAS DUE TO EXCESSIVE FORCE. THE PHYSICIAN ALSO MENTIONED HE HAD TROUBLE DEFLATING THE BALLOON. THE CATHETER WAS EXAMINED AND THE BALLOON HAD SLID OVER THE INFLATION DEFLATION HOLES. THE PHYSICIAN ATTEMPTED TO REMOVE THE HIGH-GRADE STENOSIS WITH THE CATHETER. WHEN HE REALIZED THE PULL FORCE REQUIRED TO REMOVE THE STENOSIS WAS BEYOND THE CAPACITY OF THE CATHETER, HE TRIED TO DEFLATE THE BALLOON. THE BALLOON DID NOT DEFLATE, BECAUSE THE INITIAL PULL THROUGH THE STENOSIS HAD PUSHED THE BALLOON LIGATURES OUT OF PLACE. IN CONCLUSION, THE DEVICE WAS NOT THE ROOT CAUSE OF PT INJURY. ADD'L MODEL # 1601-58, ADD'L CAT # 1601-58, ADD'L LOT # SLC1080, ADD'L EXP DATE 05-2007.

    Description of Event or Problem · 1

    TWO EMBOLECTOM,Y CATHETERS WERE USED IN THE A. BRACHIAL AND THE TIPS OF THE CATHETERS BROKE OFF AND REMAINED IN THE ARTERY. AN ACUTE ISCHEMIA OF THE AREA FORMED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE TIPS, BUT ONLY ONE WAS SUCCESSFULLY REMOVED. TO ALLEVIATE THE ISCHEMIA OF THE AREA, A BYPASS FROM THE A. BRACHIALIS TO THE DISTAL A. RADIALIS WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LUMEN EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. 1601-48 SLC1175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention