BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1820344 · Received August 30, 2010

    Report

    Report Number
    9610978-2010-00166
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PRODUCT HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 10/1/2010 INDICATED THAT THE BALLOON MATERIAL WAS REMOVED FROM THE PATIENT SURGICALLY. COMPLAINT CONCLUSION: AN OPTA PRO BALLOON BURST AT 16 ATMOSPHERES (RATED BURST PRESSURE FOR THIS BALLOON IS 10 ATMOSPHERES) AND FRAGMENTS OF THE BALLOON MATERIAL AND DISTAL CATHETER TIP SEPARATED FROM THE CATHETER BODY. ALL OF THE DEVICE MATERIAL WAS SURGICALLY REMOVED. THE TARGET LESION WAS A STENOTIC AV FISTULA LOCATED IN THE PATIENTS ARM. THE DEVICE APPEARED NORMAL PRIOR TO USE AND PREPPED NORMALLY. THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE DEVICE TO THE LESION OR REMOVING THE DEVICE FROM THE PATIENT, AND THERE WAS NO EXCESSIVE TORQUING. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THERE WERE VESSEL CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY VESSEL CHARACTERISTICS, AS WELL AS PROCEDURAL FACTORS. ONE NON STERILE UNIT OPTA PRO 10 MM X 4 CM AND 80 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED SEPARATED INTO TWO PARTS, ONE PART CONTAINED A PARTIAL PART OF THE BALLOON WITH A COMPLETE CATHETER SHAFT AND HUB, THE OTHER PART CONTAINED A COMPLETE DISTAL TIP JOINED TO A PARTIAL PART OF THE BALLOON, ONLY THE PROXIMAL MARKER BAND WAS PRESENT ON UNIT, DISTAL MARKER BAND WAS NOT PRESENT ON RECEIVED UNIT. DRY BLOOD RESIDUES WERE OBSERVED IN CATHETER. THE INNER BODY APPEARS AS IF IT HAS BEEN ELONGATED. FUNCTIONAL ANALYSIS WAS NOT PERFORMED SINCE RECEIVED UNIT WAS RECEIVED SEPARATED IN TWO PARTS. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF MATERIAL SPLITS/ABRASIONS. THE SAMPLE EXHIBITED NO EVIDENCE OF INTERNAL SURFACE DAMAGE. MINIMAL DELAMINATION COULD BE OBSERVED ALONG THE TEAR EDGE; HOWEVER THIS IS A COMMON SURFACE CHARACTERISTIC FOR THIS FAILURE MODE. THE BODY OF THE CATHETER WAS FOUND TO BE TORN APART; BOTH ENDS PRESENT IRREGULAR PATTERNS AND ELONGATIONS. THESE ARE CHARACTERISTICS OF PIECES THAT WERE SUBJECTED TO PULLING/STRETCHING UNTIL FAILURE. THE MARKER BAND WAS DETACHED FROM THE BODY, BUT EXHIBITED NO EVIDENCE OF DAMAGE. THE CATHETER BODY PRESENTED EVIDENCE OF THE MARKER BAND BEING ATTACHED TO IT. 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. THE REPORTED BALLOON BURST WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    IT IS ANTICIPATED THAT THE PRODUCT WILL BE RETURNED, BUT IT HAS NOT YET BEEN RETURNED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2010: THE AV FISTULA WAS ON THE PATIENT'S ARM. THE DEVICE APPEARED NORMAL PRIOR TO USE AND PREPPED NORMALLY. THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE DEVICE TO THE LESION OR REMOVING THE DEVICE FROM THE PATIENT, AND THERE WAS NO EXCESSIVE TORQUING. ALL OF THE MATERIAL WAS REMOVED FROM THE PATIENT. THE DEVICE WAS RETURNED FOR ANALYSIS ON 9/29/2010, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AN OPTA PRO 10X4 80CM BALLOON BURST AT 16ATM AND FRAGMENTS OF THE BALLOON MATERIAL AND DISTAL CATHETER TIP SEPARATED FROM THE CATHETER BODY AND REMAINED IN THE PATIENT'S VESSEL. THE TARGET LESION WAS A STENOTIC AV FISTULA.

    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. NA 14136509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention