BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY 7FR. 40CC IAB

    MDR report key: 12180408 · Received July 16, 2021

    Report

    Report Number
    2248146-2021-00459
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 23, 2021
    Report Date
    February 2, 2022
    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 PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED WITH BLOOD ON THE EXTERIOR AND HEAVY BLOOD INSIDE THE STATGARD SLEEVE. A CATHETER TUBING KINK WAS OBSERVED APPROXIMATELY 31.24CM FROM THE IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTENDER TUBING, AND EXTRACORPOREAL TUBING AND NO LEAKS WERE DETECTED. A SMOOTH INSERTION OF THE GUIDEWIRE WAS OBSERVED. UNABLE TO CONFIRM THE REPORTED MIGRATION DUE TO THE RETURNED CONDITION OF THE IAB. HOWEVER, THE REPORTED STATGARD LEAK WAS LIKELY CAUSED DUE TO THE STATGARD TIP BEING ENGAGED WITH THE SHEATH HUB. 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 THROUGH 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 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 THROUGH 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

    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 ONCE THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED, ITS POSITIONING WAS FREQUENTLY DISPLACED. THE POSITIONING WAS CORRECTED UNDER FLUOROSCOPY. BLOOD HAS ADHERED TO THE INSIDE OF THE CONTAMINATION SHIELD AND BECAME UNCLEAN SO THE IAB WAS REPLACED. IT WAS NOTED THAT THE PATIENT'S BLOOD VESSEL MEANDERING WAS MILD, BLOOD PRESSURE WAS NOT HIGH, NO INFECTIOUS DISEASE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080018 TRANS-RAY 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000123658

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male UNKNOWN.