BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1083430 · Received July 29, 2008

    Report

    Report Number
    1219856-2008-00059
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    December 20, 2007
    Report Date
    July 29, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY DETERMINED TO BE REPORTABLE BY ALTERNATE SUMMARY REPORT (RUPTURED BALLOON); EVAL CONCLUDED OTHERWISE. EVALUATION: THE INTRA-AORTIC BALLOON (IAB) WAS RETURNED, THE PUMP TUBING. GUIDEWIRES & SHEATH WERE NOT RETURNED. THERE WAS BLOOD ON ALL INTERIOR SURFACES OF IAB & SHORT TUBING. SLIGHT TRACES OF BLOOD WERE ON EXTERIOR SURFACE OF UNIVERSAL SHEATH. VACUUM WAS PULLED ON IAB & DID NOT HOLD. IAB WAS SUBMERGED & PRESSURIZED IN WATER. BUBBLES EXITED BOTH DISTAL TIP & LUER END OF IAB INDICATING A BROKEN CENTRAL LUMEN. BOTH ENDS OF IAB WERE BLOCKED. NO OTHER LEAKS WERE DETECTED IN IAB OR BLADDER. IT APPEARED THAT EXCESSIVE FORCE WAS PLACED ON IAB DURING OR FOLLOWING INSERTION. PRODUCT'S INSTRUCTIONS FOR USE CAUTIONS: "FRACTURE OF THE NITINOL CENTRAL LUMEN ALLOWING COMMUNICATION BETWEEN THE GAS LUMEN AND CENTRAL LUMEN HAS BEEN REPORTED, REQUIRING INTERRUPTION OF CIRCULATORY SUPPORT. OBSTRUCTION TO PASSAGE OF A GUIDEWIRE THROUGH FRACTURED NITINOL TUBING CAN OCCUR, MAKING IT DIFFICULT TO REINSERT GUIDE WIRE TO FACILITATE REPOSITIONING OR REPLACEMENT OF INTRA-AORTIC BALLOON CATHETER. WHILE FRACTURE IS MORE LIKELY TO OCCUR WHEN EXCESSIVE MANIPULATIVE FORCE IS USED, FREEDOM FROM FRACTURES HAS NOT BEEN ESTABLISHED WITH NORMAL USE." A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON IAB & IT MET ALL SPECIFICATIONS & PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN DHR & REPORTED COMPLAINT. IT WAS DETERMINED THAT A CENTRAL LUMEN BREAK DUE TO EXCESSIVE FORCE WAS THE CAUSE OF THE REPORTED COMPLAINT. MANAGEMENT WILL CONTINUE MONITORING COMPLAINT REPORTS FOR ANY TRENDS WHICH MAY APPEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER INSERTION - BLOOD FLEW FROM THE PUMPING ENTRY." THERE IS LIMITED INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF7086557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK