BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 10057130 · Received May 14, 2020

    Report

    Report Number
    2248146-2020-00252
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    April 28, 2020
    Report Date
    June 12, 2020
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A - SEX: FROM: UNKNOWN TO: MALE. SECTION A - DATE OF BIRTH: FROM: [BLANK] TO: 10/18/1967. SECTION A - AGE AT TIME OF EVENT: FROM: [BLANK] TO: 52. SECTION A - AGE UNITS (PATIENT): FROM: [BLANK] TO: YEARS. SECTION A - WEIGHT: FROM: [BLANK] TO: 83. SECTION A - WEIGHT (UNITS): FROM: [BLANK] TO: KGS. SECTION B - ADVERSE EVENT/PRODUCT PROBLEM: FROM: PRODUCT PROBLEM TO: ADVERSE EVENT & PRODUCT PROBLEM. SECTION B - DESCRIBE EVENT OR PROBLEM. FROM: IT WAS REPORTED DURING INTRA-AORTIC BALLOON(IAB) THERAPY, THE BALLOON RUPTURED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THERE WAS NO REPORTED INJURY TO THE PATIENT. TO:IT WAS REPORTED DURING INTRA-AORTIC BALLOON(IAB) THERAPY, THE BALLOON RUPTURED AND AN AUTOFILL ALARM OCCURRED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE FACILITY REPORTED THAT THE PATIENT EXPERIENCED A BLOOD CLOT. THE IAB WAS REPLACED AND THERAPY WAS CONTINUED. SECTION D - BRAND NAME: FROM: UNKNOWN IAB TO: LINEAR 7.5 FR. 40CC IAB. SECTION D - LOT #: FROM: UNKNOWN TO: 3000106389. SECTION D - EXP. DATE: FROM: [BLANK] TO:10/10/2022. SECTION D - CATALOG #: FROM: UNKNOWN TO: 0684-00-0475. SECTION D - DEVICE AVAILABLE FOR EVAL? FROM: YES TO: NO. SECTION G - PMA/510(K)#" FROM: [BLANK] TO: K041281. SECTION H - MANUFACTURE DATE: FROM: [BLANK] TO: 10/10/2019. SECTION H - TYPE OF REPORTABLE EVENT: FROM: MALFUNCTION TO: SERIOUS INJURY. SECTION H - EVALUATION METHOD CODES: ADDED: ANALYSIS OF PRODUCTION RECORD; 3331, ADDED: TREND ANALYSIS; 4110, ADDED: HISTORICAL DATA ANALYSIS; 4109. 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 DURING INTRA-AORTIC BALLOON(IAB) THERAPY, THE BALLOON RUPTURED AND AN AUTOFILL ALARM OCCURRED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE FACILITY REPORTED THAT THE PATIENT EXPERIENCED A BLOOD CLOT. THE IAB WAS REPLACED AND THERAPY WAS CONTINUED.

    Additional Manufacturer Narrative · 1

    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 DURING INTRA-AORTIC BALLOON(IAB) THERAPY, THE BALLOON RUPTURED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521959 LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000106389

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other