BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERFORM BALLOON

    MDR report key: 5029615 · Received August 25, 2015

    Report

    Report Number
    2029214-2015-00929
    Event Type
    Death
    Date Received
    August 25, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 29, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MJN
    PMA / PMN Number
    K091458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION WITH A GUIDEWIRE. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD NOTED THROUGHOUT THE DEVICE AND THE INFLATION HOLES WERE OCCLUDED WITH DRIED BLOOD. THE CATHETER¿S INNER LINER AND COIL WERE FOUND TO BE STRETCHED WITH AN ACCORDION APPEARANCE AT THE DISTAL SECTION. THE BALLOON SUB-ASSEMBLY WAS ALSO FOUND TO BE ELONGATED WITH A NECKING APPEARANCE AT THE DISTAL SECTION AND AT PROXIMAL MARKER BAND SECTION. DUE TO THE CATHETER¿S DAMAGED CONDITION IT COULD NOT BE TESTED. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS, THE CAUSE OF THE NON-DEFLATION COULD NOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT BLOOD MAY HAVE ENTERED INTO THE BALLOON¿S SUB-ASSEMBLY DURING THE PROCEDURE OCCLUDING THE INFLATION HOLES CONTRIBUTING TO THE REPORTED EVENT. PER THE OCCLUSION BALLOON SYSTEM IFU: " DO NOT WITHDRAW THE GUIDEWIRE TO DEFLATE THE BALLOON; INSTEAD PULL NEGATIVE ON THE SYRINGE TO DEFLATE. THE BALLOON SHOULD ALWAYS BE DEFLATED WITH THE GUIDEWIRE REMAINING BEYOND THE CATHETER TIP IN ORDER TO MINIMIZE ASPIRATION OF BLOOD INTO THE LUMEN." IN ADDITION, AFTER MULTIPLE INFLATIONS, THE CATHETER AND GUIDEWIRE SHOULD BE REMOVED AND INSPECTED. VERIFY THE PERFORMANCE OF THE BALLOON AND INSPECT IT FOR THE PRESENCE OF CLOTS AT THE TIP OR INFLATION HOLES. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. REFERENCE (B)(4) FOLLOW UP 1.

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAVE BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED.THE DEVICE HAS NOT BEEN RECEIVED. ONCE THE DEVICE IS RECEIVED A SUPPLEMENTAL REPORT WILL BE RESUBMITTED WITH THE ANALYSIS FINDINGS.(B)(4)

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THAT DURING THE TREATMENT OF A BASILAR ARTERY ANEURYSM THE HYPERFORM BALLOON FAILED TO DEFLATE DURING THE PROCEDURE. THE PHYSICIAN WAS INITIALLY ABLE TO DEFLATE AND INFLATE THE OCCLUSION BALLOON. AFTER READJUSTMENT OF THE MICROCATHETER POSITION THE FOLLOW UP RADIOGRAPHY REVEALED THAT THE ANEURYSM WAS BLEEDING. THE PHYSICIAN IMMEDIATELY INFLATED THE BALLOON TO OCCLUDE THE VESSEL AND QUICKLY FILL THE ANEURYSM WITH A COIL. HOWEVER UPON THE DETACHMENT OF THIS COIL, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON BUT THE BALLOON DID NOT RESPOND TO THIS AND OTHER ATTEMPTS TO DEFLATE THE BALLOON. THE PHYSICIAN ULTIMATELY HAD TO PULL ON THE OCCLUSION BALLOON CATHETER TO REMOVE IT. AFTER REMOVAL OF THE BALLOON CATHETER THE FOLLOW UP RADIOGRAPHY REVEALED BLEEDING. THEREFORE, THE PHYSICIAN USED A NEW BALLOON SYSTEM TO CONTROL THE BLEEDING. THE PROCEDURE WAS THEN COMPLETED BUT THE PATIENT STILL WAS UNABLE TO BREATH SPONTANEOUS. THE PATIENT DID NOT HAVE IMPROVEMENT FROM BASELINE STATUS. PRIOR TO THE TREATMENT, THE PATIENT SUDDENLY BECAME UNCONSCIOUSNESS WITH NO CLEAR TRIGGER/CAUSE, WITH HYPERSPASMIA AND INCONTINENCE. THE PATIENT WAS TAKEN TO THE LOCAL HOSPITAL AND RECEIVED: CRANIAL COMPUTED TOMOGRAPHY (CT) - SUBARACHNOID HEMORRHAGE. THE PATIENT WAS INTUBATED, DEHYDRATION, AND PROVIDED WITH TREATMENT FOR PREVENTION OF CEREBRAL VASOSPASM. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) FOR FURTHER TREATMENT. THE PATIENT WAS IN A COMA AND PRESENTED WITH BILATERAL DILATED PUPILS, WITHIN NO SPONTANEOUS BREATHING, LIMB MUSCLE STRENGTH WAS LEVEL FOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562779 HYPERFORM BALLOON CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN COVIDIEN (IRVINE) 104-4420 9980598

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| R