BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER ¿ THERMOCOOL® BI-DIRECTIONAL CATHETER

    MDR report key: 2884588 · Received December 23, 2012

    Report

    Report Number
    9673241-2012-00380
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO PRODUCT ANALYSIS RESULTS FOR TWO CATHETERS RETURNED. (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, A BUBBLE ERROR WAS OBSERVED ON THE COOL FLOW PUMP WHICH WAS RESOLVED TEMPORARILY BY EXCHANGING THE COOL FLOW TUBING. THE BUBBLE ERROR RE-APPEARED AGAIN AFTER 30 SECONDS AND WHEN THE CATHETER WAS PULLED, A CLOT ON IT WAS NOTICED. BY EXCHANGING THE CATHETER AND THE COOL FLOW TUBING TWICE DID NOT RESOLVE THE ISSUE. THE CASE WAS CONTINUED WITH BOSTON SCIENTIFIC CATHETER. CATHETER # 1 - PRODUCT ANALYSIS #: (B)(4) THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. AN IRRIGATION TEST WAS ALSO PERFORMED AND CATHETER FAILED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBING NEAR THE TIP AREA WAS OCCLUDED APPARENTLY WITH BLOOD. NO OTHER FOREIGN MATERIAL WAS BLOCKING THE TUBING. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, IT COULD NOT BE DETERMINED HOW THE IRRIGATION PORTS WERE OCCLUDED. CATHETER #2 - PRODUCT ANALYSIS #: (B)(4) THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. AN IRRIGATION TEST WAS ALSO PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE CATHETER PASSED SPECIFICATIONS. HOWEVER, THE ROOT CAUSE OF THE CLOT REMAINS UNKNOWN. LOT NUMBER FOR BOTH CATHETERS ANALYZED WAS 15712848M. 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 DURING AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, A BUBBLE ERROR WAS OBSERVED ON THE COOL FLOW PUMP WHICH WAS RESOLVED TEMPORARILY BY EXCHANGING THE COOL FLOW TUBING. THE BUBBLE ERROR RE-APPEARED AGAIN AFTER 30 SECONDS AND WHEN THE CATHETER WAS PULLED, A CLOT ON IT WAS NOTICED. NO INJURY TO THE PATIENT WAS REPORTED. BY EXCHANGING THE CATHETER AND THE COOL FLOW TUBING TWICE DID NOT RESOLVE THE ISSUE. THE CASE WAS ABANDONED WITH EZ STEER THERMOCOOL BI-DIRECTIONAL CATHETER AND IT WAS CONTINUED WITH BOSTON SCIENTIFIC CATHETER. AFTER FOLLOW UP WITH THE CUSTOMER IT WAS STATED THAT THE PHYSICIAN BELIEVES THAT THERE WERE NO TRUE BUBBLES IN THE TUBING. AND THAT THE CLOT WAS NOT RELATED TO BUBBLE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER ¿ THERMOCOOL® BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1294-05-S 15712848M

    Patients

    Seq Age Sex Outcome Treatment
    1