BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY 7FR. 40CC IAB

    MDR report key: 12134944 · Received July 8, 2021

    Report

    Report Number
    2248146-2021-00441
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 18, 2021
    Report Date
    November 16, 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 JUL-19 TO JUN-21 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT #484863. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. A NON MAQUET SHEATH WAS RETURNED SEPARATE FROM THE CATHETER. THE INNER LUMEN WAS FOUND OCCLUDED WITH DRIED BLOOD. THE OCCLUSION WAS UNABLE TO BE CLEARED. 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 PUMPED FOR TWO HOURS WHICH REPRESENTS ONE COMPLETE AUTOFILL CYCLE. THE IAB PUMPED NORMALLY AND 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 JUL-19 TO JUN-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 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.

    Additional Manufacturer Narrative · 1

    (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 IMMEDIATELY AFTER INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE FREQUENTLY GENERATED CHECK IAB CATHETER AND CATHETER RESTRICTION ALARMS. THE IAB WAS CHECKED AND NO ISSUES WERE FOUND. THE CONSOLE WAS SWAPPED OUT WITH A DIFFERENT ONE, BUT THE PROBLEM CONTINUED. THE EXTENSION TUBE WAS REMOVED AND THE EXPANSION OF THE IAB WAS CONFIRMED BY FLUOROSCOPY WHILE PUSHING IT BY HAND WITH A SYRINGE. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE, BUT THE ISSUE WAS NOT RESOLVED AND THE CAUSE COULD NOT BE DETERMINED. WHEN THE AUGMENTATION PRESSURE WAS LOWERED, THE DRIVE BECAME STABLE AND THE ALARM COULD BE AVOIDED SO THERAPY WAS CONTINUED. APPROXIMATELY 16 HOURS LATER, THE SECOND IAB WAS ALSO REMOVED. IT WAS NOTED THAT ANOTHER MANUFACTURER'S SHEATH WAS USED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE SECOND IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST IAB USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034404 TRANS-RAY 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000123658

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male CARDIOSAVE / TERUMO CORPORATION 8FR SHEATH