BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 116406 · Received August 30, 1997

    Report

    Report Number
    2248146-1997-00900
    Event Type
    Injury
    Date Received
    August 30, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 5, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. THE PHYSICAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTENT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND NEEDED TO BE SURGICALLY REMOVED FROM THE PT. THE SMOOTH-EDGED MEMBRANE PENETRATION(S) MOST LIKELY RESULTED DURING BALLOON REMOVAL FROM THE PT WHEN THE IAB CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT. ALTHOUGH THE PT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY CAUSE THE BALLOON TO BECOME TOO LARGE FOR PERCUTANEOUS REMOVAL OR TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS IN THE INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, YOU WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.

    Description of Event or Problem · 1

    AFTER IABP FOR TEN DAYS, THE DR TRIED TO REMOVE THE IAB BUT WAS UNABLE TO. THE IAB WAS ENTRAPPED AND NEEDE TO BE SURGICALLY REMOVED. NO ALARM SOUNDED FROM THE KONTRON PUMP AND NO BLOOD WAS NOTED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 8/26/97: WHEN THE IAB WAS TO BE REMOVED ON 8/6/97, THE TIP OF THE BALLOON WOULD NOT EXIT THE ARTERY. THE PT HAD TO WAIT A FEW HRS UNTIL A VASCULAR SURGEON COULD SURGICALLY REMOVE THE IAB BY DOING A CUTDOWN. THE PT THEN NEEDED A REPAIR OF THE RCFA, ENDARTERECTOMY AND REPAIR WITH A DACRON GRAFT. AFTER THE EVENT, THE PT DID HAVE PULSES IN THE LEG WITH NO APPARENT ILL EFFECTS OR DEFICIT. EVENT COMPLICATIONS: THE IAB WAS ENTRAPPED/SURGICALLY REMOVED - RPT'D 8/5/97 & 8/26. PT CURRENT STATUS: GOOD PULSES - RPT'D 8/26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0269 2/22/99

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention