BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YAMATO PLUS-R 7.5FR. 30CC IAB

    MDR report key: 12568337 · Received October 4, 2021

    Report

    Report Number
    2248146-2021-00644
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 13, 2021
    Report Date
    December 2, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 (3331/213) - 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 (4109/213) - THE REVIEW OF THE HISTORICAL DATA WAS PERFORMED. TREND ANALYSIS (4110/213) - THE OVERALL COMPLAINT TREND DATA FOR THE PERIOD SEP-19 THROUGH AUG-21 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD FOUND ON THE EXTERIOR OF THE CATHETER. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CS300 PUMP AND THE IAB FULLY INFLATED. NO ALARM SOUNDED FROM THE PUMP. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. A NON-CONFORMING MATERIAL REPORT REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. ANALYSIS OF PRODUCTION (3331/213) - 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 (4109/213) - THE REVIEW OF THE HISTORICAL DATA WAS PERFORMED. TREND ANALYSIS (4110/213) - THE OVERALL COMPLAINT TREND DATA FOR THE PERIOD OCT-2019 THROUGH SEP-2021 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. COMPLAINT RECORD ID # (B)(4).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    EVENT SITE POSTAL CODE: (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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB) AND PUMPING BEGAN, IT WAS DISCOVERED VIA FLUOROSCOPY THAT THE TIP OF THE IAB WAS NOT FULLY INFLATING. THE CUSTOMER REPEATEDLY TURNED THE CONSOLE ON AND OFF, BUT THIS DID NOT RESOLVE THE ISSUE. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE, WHICH FUNCTIONED AS EXPECTED. THERE WAS NO PATIENT HARM OR ADVERSE VENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465972 YAMATO PLUS-R 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000115414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARDIOSAVE| CARDIOSAVE