BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1901873 · Received November 17, 2010

    Report

    Report Number
    9610978-2010-00244
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE BALLOON WAS INFLATED TO NORMAL WORKING PRESSURE AND DEFLATED WITHOUT ANY NOTICEABLE PROBLEMS. UPON ATTEMPTING TO RETRIEVE THE BALLOON IT WAS NOTED THAT THE DISTAL MARKER REMAINED IN PLACE ON FLOURO, THE CATHETER WAS RETRIEVED AND THE DISTAL PORTION OF THE BALLOON INCLUDING THE MARKER REMAINED IN THE BILIARY VESSEL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. A NON STERILE OPTA PRO 8.00 MM X 4CM, 80 CM WAS RETURNED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. THERE WAS A BENT DETECTED ON THE SHAFT PROBABLY DUE TO THE WAY THE UNIT WAS SENT TO ANALYSIS. NO DRIED BLOOD RESIDUES WERE NOTED ON THE CATHETER. INNER BODY, TIP AND MARKER BANDS WERE NOT RETURNED WITH COMPLAINT UNIT. CATHETER SHAFT WAS SEPARATED FROM INNER BODY. DISTAL PART OF BALLOON WAS NOT RETURNED. THE DELIVERED PART OF BALLOON PRESENTED A RADIAL RUPTURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A SCANNING MICROSCOPE ANALYSIS (SEM) ANALYSIS WAS PERFORMED TO BALLOON¿S OUTER AND INNER SURFACES TO DETERMINE THE POSSIBLE ROOT CAUSE OF THE BURST. THE BALLOON EXTERNAL AND INTERNAL SURFACES EXHIBITED EVIDENCE OF ABRASIONS AND ELONGATIONS. MINIMAL DELAMINATION COULD BE OBSERVED ALONG THE TEAR EDGE; HOWEVER THIS IS A COMMON SURFACE CHARACTERISTIC FOR THIS FAILURE MODE. THE INNER BODY PORTION THAT WAS VISIBLE PRESENTED EVIDENCE OF ELONGATIONS. THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT APPEARS THAT SEVERE PULLING UNTIL RUPTURE COULD HAVE BEEN INVOLVED. CUSTOMER COMPLAINT REPORTED AS 'BODY/SHAFT SEPARATED IN PATIENT' WAS CONFIRMED, THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTOR MIGHT HAVE CONTRIBUTED TO THE FAILURE, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS OR THE SEM ANALYSIS SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. CAUSE OF BALLOON BURST FOUND DURING THE ANALYSIS COULD NOT BE DETERMINED EITHER. PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURE, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS OR THE SEM ANALYSIS SUGGESTS THAT THIS FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN FOR THIS FAILURE EITHER. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE BALLOON WAS INFLATED TO NORMAL WORKING PRESSURE AND DEFLATED WITHOUT ANY NOTICEABLE PROBLEMS. UPON ATTEMPTING TO RETRIEVE THE BALLOON IT WAS NOTED THAT THE DISTAL MARKER REMAINED IN PLACE ON FLOURO, THE CATHETER WAS RETRIEVED AND THE DISTAL PORTION OF THE BALLOON INCLUDING THE MARKER REMAINED IN THE BILIARY VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. 15187812

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R