BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8960336 · Received September 4, 2019

    Report

    Report Number
    2029046-2019-03587
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 9, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ON (B)(6)2019 , THIS THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS RECEIVED BY THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB AS A WRONG DEVICE UNDER MANUFACTURER¿S REFERENCE # PC-000513625. MANUFACTURER REFERENCE NUMBER # PC-000513625 WAS ASSESSED AS NOT REPORTABLE FOR A FORCE ISSUE. THE FIRST VISUAL FINDING FROM THE BIOSENSE WEBSTER PRODUCT ANALYSIS LAB FOR THIS WRONG DEVICE RECEIVED WAS THAT THE DISTAL TIP APPEARED TO BE COMPRESSED AND PINCHED. THIS ISSUE WAS ASSESSED AS A REPORTABLE LAB FINDING. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT RING # 1 WAS LIFTED, WITH THE EDGES WITHOUT POLYURETHANE. THEN PER THE EVENT, AN OUTER DIAMETER (OD) TEST WAS PERFORMED AND THE CATHETER PASSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30202742L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ROOT CAUSE OF THE DAMAGE TO RING# 1 LIFTED AND THE EDGES WITHOUT P.U CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER'S REFERENCE # PC-000534609.

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS RECEIVED BY THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB AS A WRONG DEVICE UNDER MANUFACTURER¿S REFERENCE (B)(4). MANUFACTURER REFERENCE NUMBER (B)(4) WAS ASSESSED AS NOT REPORTABLE FOR A FORCE ISSUE. THE FIRST VISUAL FINDING FROM THE BIOSENSE WEBSTER PRODUCT ANALYSIS LAB FOR THIS WRONG DEVICE RECEIVED WAS THAT THE DISTAL TIP APPEARED TO BE COMPRESSED AND PINCHED. THIS ISSUE WAS ASSESSED AS A REPORTABLE LAB FINDING. AN INVESTIGATION WAS PERFORMED TO DETERMINE IF THERE WAS AN EXISTING MANUFACTURER REFERENCE NUMBER FOR THIS WRONG DEVICE RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS PRODUCT DOES NOT BELONG TO ANY COMPLAINT. THEREFORE, SINCE THE RETURNED CATHETER CONDITION HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION, WE HAVE MADE THE DECISION TO CREATE A RELATED MANUFACTURER REFERENCE NUMBER UNDER (B)(4) TO CONSERVATIVELY REPORT THIS RETURNED CATHETER CONDITION. THE AWARENESS DATE IS (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754731 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30202742L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1