BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    MDR report key: 6038005 · Received October 18, 2016

    Report

    Report Number
    1820334-2016-01149
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 30, 2016
    Report Date
    March 21, 2017
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002096318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS CASE WAS REVIEWED BY OUTSIDE PROFESSIONAL CLINICAL REVIEW. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THIS PRODUCT WAS SHIPPED WITH AN IFU, WHICH STATES UNDER PRECAUTIONS: "DUE TO THIN WALL CONSTRUCTION, EXTREME CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL. CATHETER INSERTION THROUGH A SYNTHETIC VASCULAR GRAFT SHOULD BE AVOIDED WHENEVER POSSIBLE." IT ALSO STATES, ¿THE POSSIBLE WHIPLASH EFFECT OF THE LONG, SOFT CATHETER TIP MUST BE CONSIDERED DURING SELECTIVE ANGIOGRAPHY." THE DEVICE HISTORY RECORD WAS REVIEWED AND TWO NON-CONFORMANCES WERE NOTED IN THE PRODUCTION DEPARTMENT. A REVIEW OF THE NON-CONFORMANCE DATA REVEALED THAT THE NON-CONFORMANCE LISTED ON THE DEVICE HISTORY RECORD WAS FOR TIP DAMAGE AND BOND SEPARATION. THESE NON-CONFORMANCES WERE NOT RELATED TO THE REPORTED FAILURE. THE AFFECTED PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION. VISUAL EXAMINATION OF THE COMPLAINT PHOTOS SHOW THE DISTAL END IS SEPARATED FROM THE CATHETER. THE CATHETER ALSO APPEARS TO HAVE BLOOD MATTER ON IT. ADDITIONALLY, A SLIGHT ELONGATION WAS NOTED IN THE TIP MATERIAL. THE DISTAL TIP WAS NOT RETURNED TO ASSIST IN THIS INVESTIGATION. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS HEAVILY CALCIFIED. BASED ON THE AVAILABLE INFORMATION THE EXACT CAUSE OF THE ISSUE IS NOT CLEAR. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TRANSJUGULAR BIOPSY (BX) PROCEDURE THE 7FR SHEATH FRACTURED AT THE DISTAL TIP WHILE GAINING ACCESS THROUGH THE RIGHT HEPATIC VEIN IN THE LIVER OF A TORTUOUS ANATOMY. (180334-2016-01148). THE FRACTURE OF THE SHEATH LED TO BOTH THE MEMORY POLYP BASKETS (MPB) AND ANOTHER MANUFACTURERS GLIDE CATHETER DISTAL TIPS BEING SHEARED OFF AND REMAINING IN THE PATIENT, THE GLIDE CATHETER WAS RETRIEVED USING A SNARE. THE COOK MPB WAS LOCATED IN THE PULMONARY ARTERY AND UNABLE TO BE RETRIEVED..(1820334-2016-01149). THE DECISION WAS MADE TO LEAVE THE PIECE OF MPB CATHETER INSIDE THE PATIENT ANATOMY, AS IT CURRENTLY DOES NOT APPEAR TO POSE SERIOUS RISK TO THE PATIENT. FURTHERMORE, ATTEMPTS TO RETRIEVE WERE DETERMINED TO POSSIBLY YIELD A GREATER RISK THEN LEAVING IT AS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688983 TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC N/A 00827002096318

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention