BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-MED II

    MDR report key: 761850 · Received September 11, 2006

    Report

    Report Number
    2523676-2006-00069
    Event Type
    Other
    Date Received
    September 11, 2006
    Date of Event
    July 24, 2006
    Report Date
    August 28, 2006
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THE INCIDENT IS BEING RETAINED BY THE FACILITY AND IS NOT AVAILABLE FOR THE MFR TO EVALUATE. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PEFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THESE BALLOON CATHETERS ARE MFG AND PURCHASED FROM NUMED, INC. ALL AVAILABLE INFO HAS BEEN FORWARDED TO NUMED FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. AT THIS TIME, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AFTER INFLATING THE BALLOON FOR THE 7TH TIME, THE BALLOON RUPTURED. WHILE REMOVING THE BALLOON VIA THE SHEATH, THE BALLOON (ALONG WITH THE INTRODUCER) SHEERED OFF AND BECAME LODGED IN THE RIGHT FEMORAL ARTERY (RFA). AFTER MANY UNSUCCESSFUL ATTEMPTS AT REMOVAL, THE LEFT FEMORAL ARTERY (LFA) WAS ACCESSED AND PERCLOSED AND USING A GOOSENECK SNARE. THE BALLOON WAS SNARED AND PULLED INTO THE LFA. HOWEVER, THE BALLOON WOULD NOT EXIT VIA LFA. BY THIS TIME, THE PHYSICIAN ALONG WITH THE VASCULAR SURGEON RESIDENT WERE AT THE BEDSIDE. IN THE MEANTIME, ANOTHER PHYSICIAN CONTINUED ATTEMPTING TO REMOVE THE BALLOON. AS PLANS WERE BEING MADE TO TAKE THE PT TO VASCULAR SURGERY, THE SHEATH, WIRE AND BALLOON ALL CAME OUT INTACT FROM THE LFA. AFTER THE EQUIPMENT WAS REMOVED, LFA WAS PERCLOSED. NO BLEEDING OR HEMATOMA WAS NOTED IN THE LEFT GROIN. PRESSURE DRESSING WAS APPLIED. PT'S HEMOGLOBIN AND HEMATOCRIT PRE-PROCEDURE WAS 9.8/33.1. DUE TO LARGE AMOUNT OF BLOOD LOSS DURING RETRIEVAL PROCESS, THE SECOND SURGEON ORDERED TWO UNITS PACKED RED BLOOD CELLS TO BE GIVEN. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ADDITIONAL INFO RECEIVED FROM THE FACILITY INDICATED THE CATHETER WAS REMOVED WITHOUT INCIDENT AND THE PT SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THIS EVENT. THE SAMPLE IS BEING RETAINED BY THE FACILITY AT THIS TIME AND IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED II BALLOON DILATION CATHETER LIT B. BRAUN MEDICAL INC. PDZ663 ZZ-3442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other