BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5 FR. 40CC IAB

    MDR report key: 12409051 · Received September 1, 2021

    Report

    Report Number
    2248146-2021-00562
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 6, 2021
    Report Date
    December 7, 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 AUG-19 THROUGH JUL-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).

    Additional Manufacturer Narrative · 0

    THE GUIDE WIRE WAS RETURNED INSIDE THE PROTECTIVE TUBING WITHOUT ANY VISIBLE BLOOD. THE IAB CATHETER WAS NOT RETURNED FOR EVALUATION. THE RETURNED GUIDEWIRE WAS FOUND TO BE KINK APPROXIMATELY 3.8CM FROM THE J-TIP. THE EVALUATION CONFIRMS THE REPORTED PROBLEM. THE KINKED GUIDE WIRE MAY HAVE OCCURRED DURING REMOVAL FROM THE PACKAGING. HOWEVER WE ARE UNABLE TO CONCLUSIVELY DETERMINE HOW THE KINK OCCURRED BECAUSE WE ARE UNABLE TO MIMIC THE CLINICAL SETTING. 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 SEP-19 TO AUG-21 WAS REVIEWED. COMMUNICATION/INTERVIEWS: (4111/213) 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

    COMPLETE EVENT SITE NAME: (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 WHILE PREPARING TO INSERT THE INTRA-AORTIC BALLOON (IAB), THE CUSTOMER NOTICED THE GUIDEWIRE WAS BROKEN. ANOTHER IAB WAS USED INSTEAD WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302921 TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000115980

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male