BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-MED II

    MDR report key: 795069 · Received December 12, 2006

    Report

    Report Number
    2523676-2006-00105
    Event Type
    Other
    Date Received
    December 12, 2006
    Date of Event
    October 12, 2006
    Report Date
    November 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 USER FACILITY AND IS NOT AVAILABLE FOR THE MFR TO EVALUATE. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED. 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

    AS REPORTED BY THE USER FACILITY : Z-MED II BALLOON WAS INFLATED IN AORTIC VALVE AND THEN RUPTURED WITH FIRST INFLATION. WHILE REMOVING BALLOON THROUGH SHEATH, SOME OF THE BALLOON SHEARED OFF AND BECAME LODGED IN PT FEMORAL ARTERY. AFTER ATTEMPTING FOR APPROX ONE HOUR TO SNARE BALLOON PIECE, VASCULAR SURGERY WAS CONSULTED. IN THE MEANTIME TWO UNITS OF PRBC'S WERE GIVEN BY PHYSICIAN FOR BLOOD LOSS DURING SNARING ATTEMPTS. ANOTHER PHYSICIAN ARRIVED TO ROOM AND AFTER DISCUSSING SITUATION WITH THE FIRST PHYSICIAN, IT WAS DETERMINED THAT THE FEMORAL CUT DOWN WOULD BE ATTEMPTED TO REMOVE BALLOON PIECE. ATTEMPTS WERE MADE BY THE SECOND PHYSICIAN FOR APPOX TWO HOURS. RETRIEVAL OF THE AORTIC BALLOON PIECE WERE UNSUCCESSFUL. THIS PT HAD SEVERE AORTIC STENOSIS. THIS PT EMERGENTLY CAME BACK TO THE CATH LAB THE NEXT DAY FOR INTERVENTION ON HIS PULSELESS COLD RIGHT LEG. MEDWATCH 3601800000-2006-8018. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE SAMPLE IS BEING RETAINED BY THE FACILITY AND IS NOT AVAILABLE FOR EVAL. THE FACILITY HAS DECLINED ANY ADD'L INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED II BALLOON DILATION CATHETER LIT B. BRAUN MEDICAL INC. PDZ667 ZZ-3396

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other