BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 7.5FR. 34CC IAB

    MDR report key: 20988731 · Received December 20, 2024

    Report

    Report Number
    2248146-2024-0000783
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 28, 2024
    Report Date
    March 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G1 CONTACT PERSON ¿ MFG SITE, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION), H11. CORRECTED FIELD: B5, D7A, H6 HEALTH EFFECT ¿ CLINICAL CODES. NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. THEREFORE, WE WERE UNABLE TO CONFIRM OR DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THERE WERE NO NCMRS IDENTIFIED WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE (3) MONTHS). BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED. COMPLAINT RECORD ID # 1180171

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN E1: FULL INITIAL REPORTER NAME: (B)(6), EVENT SITE NAME: (B)(6) HOSPITAL, FULL EVENT SITE ADDRESS: (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 · 0

    IT WAS REPORTED THAT THE AFTER OPENING INTRA AORTIC BALLOON (IAB) , BEFORE START OF THERAPY WHILE TAKING INSIDE THE SHEATH NOTICED LEAKING BLOOD AFTER THAT NOTICED BALLOON IS CRUSHED AND TORN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AFTER OPENING INTRA AORTIC BALLOON (IAB) , WHILE TAKING INSIDE THE SHEATH NOTICED LEAKING BLOOD AFTER THAT NOTICED BALLOON IS CRUSHED AND TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142188 LINEAR 7.5FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0479-07 3000388395

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female