BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 171624 · Received June 4, 1998

    Report

    Report Number
    2248146-1998-00611
    Event Type
    Malfunction
    Date Received
    June 4, 1998
    Date of Event
    May 26, 1998
    Report Date
    May 28, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IAB WAS RETURNED WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. LAB EXAMINATION OF RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EVENT DESCRIPTION AND PHYSICAL EVIDENCE, THERE WAS NO LEAK IN THE IAB. IT IS PROBABLE THAT DURING INSERTION BLOOD FLOWED BETWEEN THE FOLDS OF THE MEMBRANE AND EXITED NEAR THE CATHETER-MEMBRANE JUNCTION, LEADING TO THE PERCEPTION THAT THE BALLOON HAD LEAKED. DATASCOPE INCORPORATES THIS CHANNELING PHENOMENON INTO ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS. (THIS FOLLOW UP MDR WAS MAILED TO THE FDA ON 7/17/98)

    Description of Event or Problem · 1

    (CC# 98-00646) THE IAB LEAKED UPON INSERTION. ON 6/25/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: AFTER THE INSERTION OF THE IAB CATHETER, BLOOD WAS SEEN IN THE CENTER OF THE TUBING. THE DOCTOR STATED THAT THIS BALLOON HAD A LEAK IN IT. THE IAB WAS REMOVED BY THE DR AND ANOTHER WAS INSERTED. IT WAS UNKNOWN IF THERE WAS ANY PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. (EVENT COMPLICATIONS: UNK - REPORTED 5/28/98 AND 6/25/98.) (PT'S CURRENT STATUS: UNK - REPORTED 5/28/98).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0306 03/01/00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR