BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 14346578 · Received May 10, 2022

    Report

    Report Number
    2248146-2022-00367
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 15, 2022
    Report Date
    March 13, 2024
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K112327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FULL 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). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4 (LOT#), D4 (EXPIRATION DATE), H4 (MANUFACTURE DATE). 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

    DEVICE EVALUATION: THERE WAS NO REPORTED SERIAL # AND TWO IAB¿S WERE RETURNED FOR THE REPORTED MALFUNCTION AND EVALUATED. THE TWO IAB¿S WERE RETURNED WITH BOTH OF THE MEMBRANES COMPLETELY UNFOLDED AND TRACES OF BLOOD ON THE EXTERIOR OF THE CATHETERS. BOTH IAB¿S WERE ALSO RETURNED WITH THE EXTENDER TUBING. NO BLOOD WAS OBSERVED INSIDE EITHER OF THE RETURNED IAB CATHETERS. A KINK WAS OBSERVED ON IAB 2 CATHETER TUBING APPROXIMATELY 68.6CM FROM IAB TIP. A SECOND KINK WAS OBSERVED ON IAB 2 INNER LUMEN WITHIN THE MEMBRANE APPROXIMATELY 20.8CM FROM IAB TIP. NO KINKS WERE OBSERVED ON IAB 1. AN UNDERWATER LEAK TEST OF THE TWO IAB¿S BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL AND EXTENDER TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. NO TEARS WERE OBSERVED ON THE MEMBRANES OF BOTH IAB¿S. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. ADDITIONAL (2ND) IAB INFORMATION: SENSATION PLUS 8FR. 50CC IAB. LOT #: 3000152662. SERIAL #: (B)(6). MANUFACTURE DATE: 07APR2021. EXP DATE: 06APR2024. PMA/510(K)#: K112327. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON INSERTION OF THE INTRA-AORTIC BALLOON (IAB) THE CUSTOMER NOTICED BLOOD IN THE HELIUM TUBING. THEY IMMEDIATELY REMOVED THE IAB AND NOTICED A TEAR IN THE MEMBRANE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351868 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000148087 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.