BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7 FR - 30 CC

    MDR report key: 2854483 · Received November 29, 2012

    Report

    Report Number
    1219856-2012-00336
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT WHILE IN THE CORONARY INTENSIVE CARE UNIT (CICU) DURING INSERTION. PREVIOUS ASEPTIC AND ANTISEPTIC. THE RIGHT FEMORAL ARTERY WAS CANALIZED ON SECOND POSITION WITHOUT COMPLICATIONS, THE SPRING WIRE GUIDE (SWG) WAS ADVANCED AND WHEN TRYING TO PASS THROUGH THE INTRA-AORTIC BALLOON (IAB) IAB, 7 FR 30 CC, IT DID NOT ADVANCE AFTER APPROX 10 CM. AS A RESULT, THE IAB WAS NOT USED. MAKING USE OF THE SAME SWG, THE SECOND IAB WAS ADVANCED (8 FR 40 CC) WITHOUT COMPLICATION, USING THE IMPLEMENTS FROM THE FIRST IAB. THERE WERE NO FEMORAL ARTERY OBSTRUCTIONS BECAUSE THE SECOND IAB HAD NO ISSUES. THERE WAS NO REPORT OF PT DEATH OR COMPLICATIONS. NO MEDICAL SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A TWO HOUR DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT NOTED. THE PT OUTCOME IS THE PROCEDURE NEEDED ON WITHOUT COMPLICATIONS USING THE SECOND IAB. THE PT DID NOT HAVE A HEMATOMA AT THE PUNCTURE SITE. ADD'L INFO RECEIVED ON (B)(6) 2012 STATED THAT THE IAB WAS ADVANCED OVER THE SWG INTO THE SHEATH, BUT ONLY 10 CM. THE IAB WAS PREPPED PER INSTRUCTION WITH THE VALVE ATTACHED AND EVERYTHING WAS DONE CORRECTLY. THE DOCTOR HAD REMOVED THE SHEATH WITH THE FIRST IAB. THERE WERE NO INJURIES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC KF1080995

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR INTRA-AORTIC BALLOON PUMP