BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEL® CATHETER

    MDR report key: 7463456 · Received April 25, 2018

    Report

    Report Number
    3009903437-2018-00001
    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 PRE-REMOVAL IMAGING OF THE DEVICE DEMONSTRATED A PARTIAL FRACTURE OF THE FILTER. THE DEVICE REPORTEDLY PERFORMED AS INTENDED DURING THE INDWELLING PERIOD (22 DAYS). THE REPORT STATED THAT THE PATIENT WAS DISORIENTED AND CONFUSED WITH EPISODES OF SEVERE AGITATION DURING THE INTENSIVE CARE UNIT STAY. IN ADDITION, THE PATIENT UNDERWENT SURGICAL FIXATION OF MULTIPLE LOWER LIMB FRACTURES DURING THE INDWELLING PERIOD. IT IS NOT KNOWN WHETHER THE REPORTED PATIENT AGITATION OR SURGICAL PROCEDURES DURING THE INDWELLING PERIOD CONTRIBUTED TO THE PARTIAL FRACTURE OBSERVED AT PRE-REMOVAL. THE ANGEL® CATHETER WAS SUCCESSFULLY RETRIEVED, AND A FINAL VENOGRAM DEMONSTRATED NO RESIDUAL THROMBUS OR VESSEL INJURY. THE PATIENT'S POST-RETRIEVAL RECOVERY WAS REPORTED AS UNEVENTFUL. FILTER FRACTURES ARE A RECOGNIZED COMPLICATION FOR IVC FILTERS. AS STATED IN THE FOLLOWING WARNINGS IN THE ANGEL® CATHETER IFU (2013-0533): FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. RETRIEVAL OF THE FILTER WITH A FILTER FRACTURE PRESENT MAY RESULT IN COMPLICATIONS THAT REQUIRE SURGICAL INTERVENTION TO REMOVE THE ANGEL® CATHETER. AS THE DEVICE COULD NOT BE FULLY INVESTIGATED, THE ROOT CAUSE OF THE REPORTED PARTIAL FILTER FRACTURE IS INCONCLUSIVE BASED ON THE AVAILABLE INFORMATION. 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 TRANSFERRED TO INTERVENTIONAL RADIOLOGY DEPARTMENT FOR ANGEL® CATHETER RETRIEVAL TWENTY-TWO (22) DAYS POST-INSERTION. PRE-REMOVAL IMAGING DEMONSTRATED PARTIAL FRACTURE OF THE FILTER COMPONENT. SURGICAL PROCEDURE WAS REQUIRED FOR REMOVAL OF THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300576 ANGEL® CATHETER INFERIOR VENA CAVA FILTER AND CENTRAL VENOUS CATHETER PNS BIO2 MEDICAL INC 2012-0527 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention