BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 147185 · Received January 28, 1998

    Report

    Report Number
    2248146-1998-00053
    Event Type
    Malfunction
    Date Received
    January 28, 1998
    Date of Event
    January 14, 1998
    Report Date
    January 15, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH THE BALLOON MEMBRANE NOTED TO BE COMPLETELY UNFOLDED. AS A TEST, THE IAB WAS PLACED IN A TEST CHAMBER HAVING A 75MMHG BACK PRESSURE TO SIMULATE THE PRESSURE WITH IN THE AORTA. THE BALLOON PUMPED SATISFACTORILY AT 100 AND 140 BPM ON THE SYSTEM 97. NO ALARMS WERE TRIGGERED ON THE PUMP. AFTER 2 MINUTES OF PUMPING, AN INFLATE/DEFLATE CHART WAS RECORDED. THE CHART CONFIRMED THAT THE BALLOON FULLY INFLATED AND DEFLATED SATISFACTORILY AT 100 AND 140 BPM DURING LAB IABP TESTING. THUS, LAB EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. PROBABLE CAUSE OF DIFFICULTY: SINCE NO DEFECT WAS FOUND DURING LAB TESTING, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND THE EXAMINATION OF THE ITEM. IT WAS NOT POSSIBLE TO VERIFY THE REPORTED PROBLEM. THIS TYPE OF COMPLAINT IS ONE OF THE MOST DIFFICULT TO EVALUATE AND MUST RELY ON CONJECTURE SINCE ONE CANNOT OBSERVE WHAT THE BALLOON IS BEING SUBJECTED TO WITHIN THE AORTA. HAVING THE OPPORTUNITY TO EXAMINE THE FOLDED OR PARTIALLY FOLDED IAB MEMBRANE MAY HAVE PROVIDED SOME ADDITIONAL INSIGHT INTO THE ENCOUNTERED DIFFICULTY. THUS, IN GENERAL, INFLATION DIFFICULTIES MAY ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: 1. THE IAB MEMBRANE FAILED TO FULLY EXIT THE SHEATH. 2. THE BALLOON ENTERED A SUBINTIMAL SPACE. 3. THE BALLOON WAS PLACED TOO HIGH IN THE AORTIC ARCH OR IN THE SUBCLAVIAN ARTERY. 4. THE IAB FAILED TO COMPLETELY UNFOLD BECAUSE THE USER FAILED TO INJECT 60CC. OF AIR AS ADVISED IN THE INSTRUCTIONS FOR USE. 5. THE CATHETER KINKED WITHIN THE PATIENT PROBABLY BECAUSE OF SEVERE VESSEL TORTUOSITY AND/OR PATIENT MOVEMENT. 6. THE CATHETER KINKED OUTSIDE THE PATIENT. THE USER MAY HAVE FAILED TO SECURE THE CATHETER AND Y-FITTING TO THE PATIENT. MANIPULATION OF THE KINKED PORTION OF THE CATHETER COULD HAVE MINIMIZED THE RESTRICTION AND IMPROVE BALLOON PERFORMANCE. 7. A KINK IN THE CATHETER MAY HAVE RESTRICTED THE FLOW OF HELIUM INTO AND OUT OF THE BALLOON CAUSING IT TO NOT FULLY INFLATE DURING THE INITIATION OF IABP. 8. THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY ALLEVIATE THE PROBLEM. 9. THE BALLOON PUMP NEEDED SERVICING.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00054) THE IAB DID NOT INFLATE. NO ALARM SOUNDED FROM THE SYSTEM 97 PUMP. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT 98-00055) ON 2/20/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE BALLOON DID NOT INFLATE. THE DR DISCONTINUED THE BALLOON WITHOUT MANUAL INFLATION. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 1/14/1998. THE PT WENT ONTO EXPIRE ON 1/17/1998 AT 10:15 PM.

    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 12/10/99

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR