BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 11706128 · Received April 22, 2021

    Report

    Report Number
    2248146-2021-00251
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    April 4, 2021
    Report Date
    June 30, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K112327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTER: (B)(6) / OTHER HEALTH CARE PROFESSIONAL. 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).

    Additional Manufacturer Narrative · 0

    DESPITE REQUEST AND/ OR CUSTOMER INDICATED THAT THE DEVICE WOULD BE RETURNED; HOWEVER, THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/SERIAL NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT/SERIAL NUMBER AND REPORTED FAILURE MODE. THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD MAY-19 THROUGH APR-21 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE INDICATED THAT GAS LOSS HAD OCCURRED. THE CUSTOMER DECIDED TO REMOVE THE IAB AND REPLACE IT WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. MEDWATCH MW5100645 RECEIVED 27-APRIL-2021. EVENT DESCRIPTION FROM MEDWATCH - BALLOON PUMP ALARM NOTED "NO GAS" AND NOTED TO NOT BE INFLATING. ALL CONNECTIONS SECURE, NO EXTERNAL EVIDENCE OF LEAKAGE. RN AND CHARGE RN AT BEDSIDE. MD TO BEDSIDE AND REQUESTED ANOTHER BALLOON FOR EXCHANGE OF DEVICE. UPON REMOVAL OF PREVIOUSLY IMPLANTED BALLOON, NOTED TO HAVE LARGE HOLE. BALLOON PLACED IN BIOHAZARD BAG AND SAVED AS EVIDENCE OF EQUIPMENT FAILURE. PATIENT REMAINED GENERALLY HEMODYNAMICALLY STABLE. ALTHOUGH THERE WAS A SIGNIFICANT DROP IN SBP WHILE BALLOON OUT. PATIENT REQUIRED EMERGENT BEDSIDE SURGERY TO REPAIR FEMORAL ARTERY. PATIENT IS A (B)(6) YEAR OLD LADY WITH NO PREVIOUS CARDIAC HISTORY. SHE PRESENT TODAY FOR CHEST DISCOMFORT, DYSPNEA ON EXERTION. SHE STARTED NOTICING DYSPNEA EXERTION, CHEST DISCOMFORT WHEN SHE WAS WALKING AROUND 1 WEEK AGO. DENIES RESTING SYMPTOMS, NO ORTHOPNEA, NO PND, NO PRESYNCOPE OR SYNCOPE. SHE WENT TO SEE HER PCP EARLIER TODAY AS SCHEDULED. AN EKG WAS DONE, WHICH WAS CONCERNING FOR ACUTE CORONARY SYNDROME. SHE WAS SENT TO EMERGENCY ROOM IMMEDIATELY. SHE IS RESTING WITHOUT DISTRESS WHEN I SAW HER. NO CHEST PAIN, NO CHEST PRESSURE, NO ORTHOPNEA, NO PND. HER EKG SHOWED ST DEPRESSION, BUT NO INDICATION OF STEMI. SHE HAS BEEN HEMODYNAMICS STABLE. TROPONIN IS MILDLY ELEVATED. FDA SAFETY REPORT ID # (B)(4)

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTER: (B)(6). 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

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE INDICATED THAT GAS LOSS HAD OCCURRED. THE CUSTOMER DECIDED TO REMOVE THE IAB AND REPLACE IT WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604758 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000131135 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CARDIOSAVE / (21)CH331452L0