BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEL® CATHETER

    MDR report key: 6513424 · Received April 21, 2017

    Report

    Report Number
    3009903437-2017-00001
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 21, 2017
    Manufacturer
    BIO2 MEDICAL, INC.
    Product Code
    PNS
    PMA / PMN Number
    K160747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REFUSED TO RETURN THE INCIDENT DEVICE OR PROVIDE IMAGING OF THE DEVICE FOR EVALUATION. HOWEVER, BIO2 MEDICAL PERSONNEL WERE PERMITTED TO VISUALLY EXAMINE AND PHOTOGRAPH THE RETAINED PORTION OF THE INCIDENT DEVICE DURING AN ONSITE VISIT, BUT WERE NOT PERMITTED TO TOUCH THE DEVICE IN ANY WAY OR TO TEST OR CHECK THE PARAMETERS OF THE DEVICE. VISUAL EXAMINATION REVEALED THAT ONLY A PORTION OF THE INCIDENT DEVICE HAD BEEN RETAINED. IT WAS CONFIRMED THAT NO ADDITIONAL IMAGING OR PROCEDURAL INFORMATION WOULD BE PROVIDED TO BIO2 MEDICAL SUPPORT A THOROUGH ROOT CAUSE INVESTIGATION. THE VISUAL CONDITION OF THE DEVICE COMPONENTS IS CONSISTENT WITH THE REMOVAL PROCEDURE DESCRIBED ABOVE. A THOROUGH INTERNAL REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS LOT NUMBER (062116-408) DEMONSTRATED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATION REQUIREMENTS OF THE BIO2 MEDICAL QUALITY SYSTEM PRIOR TO ITS PRODUCTION RELEASE. IT CANNOT BE CONFIRMED (BASED SOLELY ON AN EXAMINATION OF PHOTOGRAPHS OF THE REMOVED DEVICE COMPONENTS) WHEN OR WHERE THE FILTER EXPERIENCED THE INITIAL FRACTURE. AS THE DEVICE COULD NOT BE FULLY INVESTIGATED, THE ROOT CAUSE OF THE REPORTED FILTER FRACTURE OR RELATIONSHIP (IF ANY) OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. BIO2 MEDICAL WILL REOPEN THIS INVESTIGATION IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS RECEIVED.

    Description of Event or Problem · 1

    AN INCIDENT OF A FRACTURED FILTER WAS REPORTED ON (B)(6) 2017. THE DEVICE WAS INDWELLING FOR 3 DAYS IN A PATIENT WITH MULTIPLE BONE FRACTURES. IN PRE-REMOVAL CAVAGRAM IMAGING PERFORMED ON (B)(6) 2017, THE FILTER APPEARED INTACT WITH NO CLOT BURDEN. DURING AN ATTEMPT TO RETRIEVE THE FILTER INTO THE SHEATH, IT WOULD NOT COLLAPSE. AFTER REPEATED ATTEMPTS, A SURGICAL PROCEDURE WAS PERFORMED WHERE A LARGE SHEATH WAS INSERTED AND GRASPING FORCEPS WERE USED TO POSITION THE FILTER INTO THE SHEATH. MULTIPLE WIRES ON THE FILTER STRUTS WERE FRACTURED; METAL SHARDS WERE REMOVED. A CT WAS COMPLETED AND WAS NEGATIVE FOR ANY FOREIGN BODIES. FOLLOWING THE PROCEDURE, THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292454 ANGEL® CATHETER INFERIOR VENA CAVA FILTER AND CENTRAL VENOUS CATHETER PNS BIO2 MEDICAL, INC. NA 062116-408

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention