BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEL® CATHETER

    MDR report key: 7463457 · Received April 25, 2018

    Report

    Report Number
    3009903437-2018-00002
    Event Type
    Injury
    Date Received
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BIO2 MEDICAL INC
    Product Code
    PNS
    PMA / PMN Number
    K160747
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS RECEIVED THROUGH A PUBLISHED CASE REPORT (SEE BELOW), AND ALL FOLLOW-UP INQUIRIES REGARDING THE RETURN OR IDENTIFICATION OF THE DEVICE DID NOT RECEIVE A RESPONSE. WITHOUT ACCESS TO THE DEVICE INVOLVED OR LOT NUMBER IDENTIFICATION, THE DEVICE EVENT COULD NOT BE FULLY INVESTIGATED. REVIEW OF THE SPECIFIC DHR FOR THIS DEVICE WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE CASE REPORT ALLEGES THAT A SURGICAL INTERVENTION WAS UNDERTAKEN FOR THE REMOVAL OF THE ANGEL CATHETER DUE TO THE PRESENCE OF A SIGNIFICANT THROMBUS WITHIN THE FILTER. THE CASE REPORT PRESUMED THAT THE PARTIAL FILTER FRACTURE OCCURRED DURING THE DIFFICULT RETRIEVAL PROCEDURE AND/OR THE REMOVAL TECHNIQUES USED DUE TO THE PRESENCE OF THE SIGNIFICANT THROMBUS. THE DEVICE REPORTEDLY PERFORMED AS INTENDED DURING THE INDWELLING PERIOD (7 DAYS), AND A SIGNIFICANT THROMBUS WAS CAPTURED IN THE FILTER. THE ANGEL® CATHETER WAS SUCCESSFULLY RETRIEVED, AND THE PATIENT'S POST-RETRIEVAL RECOVERY WAS REPORTED AS UNEVENTFUL. THE FOLLOWING APPLICABLE WARNINGS REGARDING DEVICE REMOVAL IN THE PRESENCE OF SIGNIFICANT THROMBUS ARE STATED IN THE ANGEL® CATHETER INSTRUCTIONS FOR USE (2013-0533): 1) DO NOT RETRIEVE FILTER IF SIGNIFICANT AMOUNT OF THROMBUS (GREATER THAN 25% OF THE VOLUME OF THE FILTER) IS OBSERVED WITHOUT ATTEMPTING TO MITIGATE WITH CLINICALLY ACCEPTABLE MEANS. 2) DO NOT USE EXCESSIVE FORCE WHEN COLLAPSING THE FILTER INTO THE OUTER SHEATH. 3) DO NOT USE EXCESSIVE FORCE WHEN WITHDRAWING THE ANGEL® CATHETER FROM THE PATIENT. THE IFU DOES NOT DEFINE WHAT CONSTITUTES CLINICALLY ACCEPTABLE MEANS FOR MITIGATING SIGNIFICANT THROMBUS, GIVEN THE UNIQUE PROFILE OF EACH PATIENT AND THE NUMBER OF THERAPY OPTIONS AVAILABLE FOR THROMBUS MITIGATION. THE ATTENDING PHYSICIANS AND SPECIALISTS TREATING THE PATIENT ARE BEST EQUIPPED TO DETERMINE THE APPROPRIATE TREATMENT FOR EACH SITUATION. HOWEVER, THE IFU CLEARLY STATES THAT THE FILTER SHOULD NOT BE RETRIEVED IF SIGNIFICANT THROMBUS IS PRESENT WITHOUT ATTEMPTING TO MITIGATE WITH CLINICALLY ACCEPTABLE MEANS, AND STATES WHAT TYPE OF HANDLING MAY CAUSE DAMAGE TO THE FILTER. AS THE DEVICE COULD NOT BE FULLY INVESTIGATED, THE ROOT CAUSE OF THE REPORTED PARTIAL FILTER FRACTURE IS PRESUMED TO BE THE DIFFICULT RETRIEVAL PROCEDURE AND/OR THE REMOVAL TECHNIQUES USED DUE TO THE PRESENCE OF THE SIGNIFICANT THROMBUS. BIO2 MEDICAL WILL CONTINUE TO MONITOR AND TREND THIS FAILURE MODE. CASE REPORT: "BROKEN WINGS: FIRST REPORTED CASES OF FRACTURED ANGEL® CATHETER, A TEMPORARY COMBINED FEMORAL VENOUS CATHETER AND RETRIEVABLE IVC FILTER DEVICE", PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR INTERVENTIONAL RADIOLOGY ON MARCH 14, 2018.

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR ANGEL CATHETER RETRIEVAL SEVEN (7) DAYS POST-INSERTION. INITIAL VENOGRAM DEMONSTRATED EXTENSIVE THROMBUS AROUND THE FILTER (>80% OF THE LUMEN DIAMETER). DUE TO THE LARGE VOLUME OF THROMBUS, IT WAS ONLY POSSIBLE TO PARTIALLY RE-SHEATH THE FILTER AND PARTIALLY REMOVE FROM THE COMMON FEMORAL VEIN. SEVERE RESISTANCE WAS MET ON THE ATTEMPT TO COMPLETELY REMOVE THE DEVICE. DUE TO CONCERNS OF RISK OF SIGNIFICANT VASCULAR INJURY, VASCULAR SURGEONS PERFORMED A SURGICAL CUT-DOWN TO REMOVE THE DEVICE. AFTER REMOVAL OF THE DEVICE WAS COMPLETE, THE FILTER WAS INSPECTED AND FOUND TO HAVE BEEN PARTIALLY FRACTURED. THE FRACTURE IS PRESUMED TO HAVE OCCURRED DURING THE DIFFICULT RETRIEVAL PROCEDURE AND/OR THE REMOVAL TECHNIQUES USED DUE TO THE PRESENCE OF THE SIGNIFICANT THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300577 ANGEL® CATHETER INFERIOR VENA CAVA FILTER AND CENTRAL VENOUS CATHETER PNS BIO2 MEDICAL INC 2012-0527 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention