BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 1132443 · Received August 21, 2008

    Report

    Report Number
    9673241-2008-00036
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P010068
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER DID NOT INDICATE A REPORTABLE COMPLAINT. BIOSENSE WEBSTER BECAME AWARE THAT THIS COMPLAINT IS A REPORTABLE MALFUNCTION UPON RECEIVING THE COMPLAINT PRODUCT ON 08/04/2008 AND OBSERVING ITS PHYSICAL CONDITION. ADDITIONAL INFORMATION WAS SUBSEQUENTLY OBTAINED, INDICATING THAT THE DOCTOR DID NOT NOTICE ANYTHING UNUSUAL DURING THE PROCEDURE. PER THE INFORMATION RECEIVED, THE PROBLEM WAS NOTICED AFTER THE DOCTOR RETRIEVED THE CATHETER AND ATTEMPTED TO CLEAN IT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. EVALUATION SUMMARY: UPON RECEIPT OF THE CATHETER, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS BROKEN AT THE PEEK HOUSING RIGHT BELOW RING ELECTRODE #2. COMPLAINT CONDITION WAS CONFIRMED. VISUAL TEST INDICATED THAT THE CATHETER SHOWED NO SIGNS OF BLOOD RESIDUE INSIDE THE BROKEN TIP INDICATING THAT THE CATHETER WAS NOT INSIDE THE PATIENT AT THE POINT OF BREAKAGE. IT WAS ALSO FOUND THAT LEAD WIRES WERE STICKING OUT OF THE BROKEN AREA. IN ADDITION, THE EDGE OF THE RING ELECTRODE SHOWED SCRATCH MARKS THAT INDICATE AN EXCESSIVE FORCE WAS APPLIED. THE COMPLAINTS DATABASE INDICATES THAT NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBERS WITH PART NUMBERS INVOLVED IN THIS COMPLAINT. IN ADDITION, LOT NUMBER 13284937 IS NO LONGER AVAILABLE IN FINISHED GOOD INVENTORY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CATHETER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PRECUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1201-19-S 13284937

    Patients

    Seq Age Sex Outcome Treatment
    1