BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCYPHOR CATHETER SYSTEM

    MDR report key: 1083672 · Received July 22, 2008

    Report

    Report Number
    2953769-2008-00025
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    BSP
    PMA / PMN Number
    K043500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: OTHER; FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE REPORTING THE EVENT.NO CONCLUSION CAN BE DRAWN. EVAL SUMMARY: THIS COMPLAINT INVOLVED A FAD CATHETER. PER THE COMPLAINT, THE BALLOON CAME OFF FROM THE CATHETER AS THE NURSE PULLED OUT THE CATHETER FROM PT. ALSO PER THE COMPLAINT, THE PT WAS OK. THE CATHETER BELONGED TO AN FAD KIT AND WAS DISPOSED. PART/LOT NUMBERS WERE NOT AVAILABLE. THE FAD KIT BELONGED TO THE HOSPITAL AND WAS NOT REPLACED. PER THE COMPLAINT, THE SC WAS ABLE TO RETRIEVE THE CATHETER BUT NOT THE OUTSIDE PACKAGE. SC SENT BACK THE CATHETER UNDER THIS RMA NUMBER. ADDITIONAL INFO WAS SUPPLIED ON THE CUSTOMER COMPLAINT FORM WHICH STATES THAT THE BALLOON CATHETER WAS PLACED AT L 1/2, L 2/3, AND L 3/4 AFTER PROVOCATIVE DISCOGRAM WAS PERFORMED. PLACING THE NEEDLE INTO L1/2 WAS DIFFICULT AS HER DISC WERE DEGENERATIVE AND POSSIBLY STARTING TO AUTO-FUSE. THERE IS ADDITIONAL INFO ON THE PROCEDURE MENTIONED ON THE CUSTOMER COMPLAINT FORM. BASED ON THE ABOVE INFO, THREE FAD CATHETERS WERE USED ON THIS PT. EVAL OF THE COMPLAINT: ONE FAD CATHETER WAS RETURNED UNDER THIS RMA NUMBER ONLY. IT IS PRESUMED THAT THE CATHETER RETURNED IS THE ONE THAT HAD DIFFICULTY DURING THE REMOVAL PROCESS AND THAT FOR THE OTHER TWO CATHETERS, THERE WERE NO ISSUES. IT IS ALSO BEING ASSUMED FROM THE INFO THAT WAS SUPPLIED, THAT THE CATHETER THAT WAS RETURNED WAS PLACED IN THE L1/2 POSITION. A VISUAL REVIEW OF THE RETURNED CATHETER INDICATED THAT THERE WAS NO BALLOON AT THE TIP OF THE CATHETER. LOOKS LIKE THE BALLOON WAS RIPPED OFF AT OR NEAR THE PROXIMAL END OF THE BALLOON. (SEE PICTURE 1). CATHETER AS RECEIVED IS EXCESSIVELY KINKED POSSIBLY DUE TO THE CATHETER BEING DISCARDED AND RETRIEVED AT A LATER TIME AS MENTIONED IN THE COMPLAINT. (SEE PICTURE 2). LOOKS LIKE THE KINKING IS NOT AS A RESULT OF THE PROCEDURE. CONCLUSION: BASED ON THE INFO SUPPLIED ON THE CUSTOMER COMPLAINT FORM, THAT THE PLACEMENT OF THE NEEDLE INTO L1/2 WAS DIFFICULT AS THE PATIENT'S DISC WERE DEGENERATED AND POSSIBLY STARTING TO AUTO-FUSE AND THE VISUAL EXAMINATION OF THE RETURNED CATHETER, IT IS POSSIBLE THAT THE CATHETER BALLOON WAS NOT ABLE TO DEFLATE COMPLETELY AND THAT EXCESSIVE PULLING COULD HAVE CAUSED THE BALLOON TO GET RIPPED OFF THE CATHETER. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    DURING AN F.A.D PROCEDURE, WHEN THE CATHETER WAS BEING REMOVED, THE TIP OF THE CATHETER, INCLUDING THE BALLOON, BROKE OFF AND WAS LEFT IN THE PT. IT WAS REPORTED THAT THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCYPHOR CATHETER SYSTEM F.A.D. CATHETER SYSTEM BSP MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR