BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON'S 7F ONE-PIECE/TOUHY-BORST CATH INTRO.

    MDR report key: 1335538 · Received February 27, 2009

    Report

    Report Number
    1625425-2009-00002
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    December 19, 2008
    Report Date
    February 27, 2009
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DYB
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS NOT RETURNED FOR INVESTIGATION NOR WAS A LOT NUMBER PROVIDED. PICTURES OF THE SAMPLE WERE AVAILABLE. BASED ON THE VISUAL EVIDENCE FROM THE PICTURES, IT APPEARS THAT THE SHEATH TUBING WAS CUT. THE SHEATH TUBING IS EXTRUDED FROM NEOFLON (TEFLON-FEP). TUBING EXTRUDED FROM THIS MATERIAL WILL STRETCH (ELONGATE) BEFORE IT BREAKS. ELONGATION AT BREAK (ELONGATION OF THE SPECIMEN AT BREAK POINT--EXPRESSED AS A PERCENTAGE) FOR NEOFLON IS 420-460%. ELONGATION IS A MEASURE OF THE DUCTILITY OF A MATERIAL DETERMINED IN A TENSILE TEST. IT IS THE INCREASE IN GAGE LENGTH (MEASURED AFTER RUPTURE) DIVIDED BY ORIGINAL GAGE LENGTH. HIGHER ELONGATION INDICATES HIGHER DUCTILITY. THE PICTURES PROVIDED DID NOT SHOW ANY INDICATION OF STRETCHING OF THE MATERIAL. BASED ON VISUAL EVIDENCE FROM THE PICTURES, THE ROOT CAUSE OF THIS ISSUE CAN NOT BE ATTRIBUTED TO MATÉRIAL DEGRADATION OR PRODUCT FAILURE/DEFECT. SHEATH SEPARATION IS MOST LIKELY THE RESULT OF THE SHEATH TUBING BEING CUT WITH A SHARP OBJECT DURING PROCEDURE. NO CORRECTIVE ACTION TAKEN. BASED ON VISUAL EVIDENCE FROM PICTURES, ROOT CAUSE OF THIS ISSUE CAN NOT BE ATTRIBUTED TO MATERIAL DEGRADATION OR PRODUCT FAILURE/DEFECT. VERIFIED INTRODUCER WAS CUT FROM PICTURES IN FILE. MATERIAL USED TO EXTRUDE SHEATH TUBING HAS AN EXTREMELY HIGH ELONGATION TO BREAK VALUE AND WILL ACTUALLY ELONGATE BEFORE IT BREAKS. THERE IS NO EVIDENCE OF ELONGATION OF THE SHEATH TUBING. IT APPEARS THAT THE SHEATH TUBING WAS CUT WITH A SHARP OBJECT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. COMPLAINTS WILL CONTINUE TO BE MONITORED TO ENSURE THE EFFECTIVENESS OF THIS CORRECTIVE ACTION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    AFTER PROCEDURE PART OF THE SHEATH BROKE OFF IN THE PATIENT. THERE WAS NO HARM TO PT AND THERE WAS NO ADDITIONAL SURGERY REQUIRED, HOWEVER, THE HOSPITAL DID ANOTHER INVASIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON'S 7F ONE-PIECE/TOUHY-BORST CATH INTRO. 7F ONE-PIECE/TOUHY-BORST CATH INTRODUCER DYB ARGON MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1