BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLOON CATHETER

    MDR report key: 287002 · Received July 20, 2000

    Report

    Report Number
    6000039-2000-00021
    Event Type
    Malfunction
    Date Received
    July 20, 2000
    Date of Event
    June 15, 2000
    Report Date
    June 26, 2000
    Manufacturer
    MEDI-TECH
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS BALLOON CATHETER WAS USED TO MEASURE AN ARTERIAL SEPTUM DEFECT. FOLLOWING REMOVAL OF THE BALLOON CATHETER FROM THE PT, IT WAS DISCOVERED THE BALLOON MATERIAL HAD DETACHED IN THE PT. THE BALLOON MATERIAL WAS NOT RETRIEVED AND IS BELIEVED TO BE IN THE PT'S PULMONARY SYSTEM. HOWEVER, IT IS BELIEVED THE PT WILL UNDERGO SURGERY. ANOTHER OCCLUSION BALLOON WAS USED PRIOR WHICH DETACHED IN THE PT'S GROIN. RETRIEVAL OF THE BALLOON MATERIAL, UTILIZING A SNARE AND FORCEPS, WAS UNEVENTFUL (PLEASE REFERENCE 6000039-2000-00022). THE PT'S CURRENT CONDITION IS NOT AVAILABLE. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE AT THIS TIME. SHOULD FURTHER DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED AT THAT TIME. TO DATE, THE DEVICE HAS NOT BEEN REC'D BY THIS MFR. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. WITHOUT EVALUATING THE DEVICE CO IS UNABLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT AT THIS TIME. CO'S DIRECTIONS FOR USE STATE "MEDI-TECH OCCLUSION BALLOON CATHETERS ARE INDICATED FOR USE FOR TEMPORARY VESSEL OCCLUSION IN APPLICATIONS INCLUDING ARTERIOGRAPHY, PREOPERATIVE OCCLUSION, EMERGENCY CONTROL OF HEMORRHAGE, CHEMOTHERAPEUTIC DRUG INFUSION AND RENAL OPACIFICATION PRESSURES. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THE INSTRUCTIONS IS NOT RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON CATHETER OCCLUSION BALLOON CATH LIT MEDI-TECH NA 2301847

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR GUIDEWIRE.