BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 142575 · Received January 9, 1998

    Report

    Report Number
    2248146-1997-01445
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    December 13, 1997
    Report Date
    December 19, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 97-01550) THE PT WAS EXTREMELY CRITICAL AND HAD A PTCA STENT, AND BYPASS SURGERY. THE IAB WAS REMOVED ON 12/13/1997. THE IAB DID NOT MALFUNCTION. THE CONTACT STATED THAT THE PT BECAME ISCHEMIC ON 12/17/1997 AND HAD A KNEE AMPUTATION. THE PT WENT ON TO EXPIRE ON 12/22/1997. THE CONTACT STATED THAT THE PT'S DEATH WAS NOT ATTRIBUTED TO THE EVENT. ON 1/28/1998, DATASCOPE RECEIVED THE FOLLOWING INFO: THE IAB WAS INSERTED INTO THE PT ON 12/12/1997 AT 1:00 P.M. ON 12/13/1997 AT 11:00 A.M. THE IAB WAS REMOVED. THE PT HAS SEVERE BLEEDING AND A TRANSFUSION WAS REQUIRED. THE PT HAD A THROMBOSIS, REMOVAL WAS REQUIRED AND THE PT HAD A AMPUTATION. [EVENT COMPLICATIONS]: ISCHEMIA/KNEE AMPUTATION-RPT'D 12/16/1997;BLEEDING-RPT'D 1/28/1998 [PT'S CURRENT STATUS]: EXPIRED-RPT'D 12/22/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O