BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA 8FR. 50CC IAB

    MDR report key: 12658477 · Received October 19, 2021

    Report

    Report Number
    2248146-2021-00680
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    May 1, 2021
    Report Date
    November 22, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108001
    PMA / PMN Number
    K091449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. ANALYSIS OF PRODUCTION (B)(4) - THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/SERIAL NUMBER. BASED ON THE REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS (B)(4) - THE REVIEW OF THE HISTORICAL DATA WAS PERFORMED. TREND ANALYSIS (B)(4) - THE OVERALL COMPLAINT TREND DATA FOR THE PERIOD SEP-19 THROUGH AUG-21 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (B)(4) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MEDWATCH MW5103751 RECEIVED 28-SEP-2021. PATIENT WAITING OHT, REQUIRED PLACEMENT OF IABP FOR WORSENING CARDIOGENIC SHOCK. RIGHT AXILLARY IABP PLACED (B)(6) 2021. REMOVED AND REPLACED IN LEFT AXILLARY (B)(6) 2021 DUE TO IABP RUPTURE ON (B)(6) 2021. LEFT AXILLARY IABP REMOVED AND REPLACED W/RIGHT FEMORAL IABP DUE TO RUPTURE ON (B)(6) 2021, PATIENT UNDERWENT OHT. SUBSEQUENTLY DISCHARGED FOR REHAB. FDA SAFETY REPORT ID # (B)(4). THIS REPORT IS FOR THE FIRST IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551222 MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0296-01 3000133094 10607567108001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown