BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARROWFLEX IAB: 8FR 30CC

    MDR report key: 6109222 · Received November 17, 2016

    Report

    Report Number
    1219856-2016-00263
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K993966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED THE IAB THERAPY WAS IN USE FOR 24 HOURS PRIOR THE NURSE NOTICING THE BLOOD. THE PUMP WAS STOPPED AND BLOOD DID NOT ENTER IT. EVALUATION: TELEFLEX RECEIVED THE DEVICE FOR ANALYSIS. A MANUAL PUMP WAS ATTACHED TO THE IAB UPON RECEIPT. THE SHORT DRIVELINE TUBING WAS RETRO FITTED TO CONNECT THE MANUAL PUMP TO THE IAB WITH A STANDARDIZED CONNECTOR. THE CONNECTOR THAT ALLOWS THE DRIVELINE TUBING TO CONNECT TO THE IAB SHORT DRIVELINE TUBING WAS NOT RETURNED WITH THE DEVICE. THE ONE-WAY VALVE WAS NOT RETURNED FOR EVALUATION. HARD BLOOD CLOTS WERE NOTED WITHIN THE BLADDER MEMBRANE UPON RETURN. THE BLADDER APPEARED TORN APPROXIMATELY 13.0CM FROM THE DISTAL TIP OF THE CATHETER. THE BLADDER THICKNESS WAS MEASURED AND WAS WITHIN SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT AND DETERMINED THAT THE OCCURRENCE RATE IS WITHIN ACCEPTABLE RISK LIMITS. SEE OTHER REMARKS SECTION. OTHER REMARKS: CONCLUSION: THE REPORTED COMPLAINT OF BLOOD IN THE HELIUM PATHWAY IS CONFIRMED BASED ON VISUAL INSPECTION OF THE DEVICE. THREE CUTS CONSISTENT WITH CONTACT FROM A SHARP OBJECT WERE FOUND ON THE BLADDER MEMBRANE ALLOWING BLOOD TO ENTER THE HELIUM PATHWAY. NO ABRASIONS WERE NOTED. THE ROOT CAUSE OF THE DAMAGE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS IN THE HELIUM CIRCUIT OF THE BALLOON. IT WAS IMPOSSIBLE TO REMOVE THE BALLOON WHICH WAS LOCKED INSIDE THE LEFT COMMON FEMORAL ARTERY. THE CLINICAL CONSEQUENCE WAS ISCHEMIA OF THE LOWER LEFT LIMB. EMERGENCY SURGERY WAS PERFORMED TO REMOVE THE BALLOON AND REPAIR THE LEFT COMMON FEMORAL ARTERY AND FOGARTY THROMBECTOMY BY THE SUPERFICIAL FEMORAL DOWNSTREAM. THE STAFF NOTICED THAT THE BALLOON CONTAINED VERY HARD BLOOD CLOTS THAT PREVENTED THE DEFLATION OF THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS IN THE HELIUM CIRCUIT OF THE BALLOON. IT WAS IMPOSSIBLE TO REMOVE THE BALLOON WHICH WAS LOCKED INSIDE THE LEFT COMMON FEMORAL ARTERY. THE CLINICAL CONSEQUENCE WAS ISCHEMIA OF THE LOWER LEFT LIMB. EMERGENCY SURGERY WAS PERFORMED TO REMOVE THE BALLOON AND REPAIR THE LEFT COMMON FEMORAL ARTERY AND FOGARTY THROMBECTOMY BY THE SUPERFICIAL FEMORAL DOWNSTREAM. THE STAFF NOTICED THAT THE BALLOON CONTAINED VERY HARD BLOOD CLOTS THAT PREVENTED THE DEFLATION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759539 NARROWFLEX IAB: 8FR 30CC INTRA- AORTIC BALLOOON PRODUCTS DSP ARROW INTERNATIONAL INC. 18F16D0024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R