BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ICE PLUS¿

    MDR report key: 6614397 · Received June 6, 2017

    Report

    Report Number
    2134265-2017-05584
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DXK
    PMA / PMN Number
    K160173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS REVEALED THAT THE TRANSDUCER DISTAL HOUSING WAS FOUND DETACHED FROM THE DRIVE CABLE. EVIDENCE OF THE 6 WELD POINTS FOUND IN THE DISTAL HOUSING AND DRIVE CABLE. ALL THE DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. IT WAS OBSERVED THAT THE CATHETER FLUSHED NORMALLY. IMPEDANCE TESTING SHOWS AN ELECTRICAL OPEN AT DISTAL WAVE FORM. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO DETACHMENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: AE OR PRODUCT PROBLEM FROM REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM TO PRODUCT PROBLEM. UPDATED: TYPE OF REPORTABLE EVENT FROM SERIOUS INJURY TO MALFUNCTION. UPDATED: DESCRIBE EVENT OR PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2017-05583. IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN ULTRA ICE¿ DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN USED THE FIRST ULTRA ICE¿, HOWEVER, IT WAS NOTICED THAT THE TIP OF ULTRA ICE¿ WAS DETACHED AFTER LONG USE AND THE CATHETER STOPPED SPINNING. ANOTHER ULTRA ICE¿ WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH USING THE THIRD ULTRA ICE¿ DIAGNOSTIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TIP DETACHES WITHIN THE CATHETER HOUSING. IT DOESN'T ACTUALLY DETACH ITSELF INTO THE PATIENT. THE CATHETER ITSELF REMAINS INTACT. THERE WAS/IS AN ISSUE WITH THE WELD AT THE TIP POINT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TIP DETACHES WITHIN THE CATHETER HOUSING. IT DOESN'T ACTUALLY DETACH ITSELF INTO THE PATIENT. THE CATHETER ITSELF REMAINS INTACT. THERE WAS/IS AN ISSUE WITH THE WELD AT THE TIP POINT.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2017-05583. IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN ULTRA ICE¿ DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN USED THE FIRST ULTRA ICE¿, HOWEVER, IT WAS NOTICED THAT THE TIP OF ULTRA ICE¿ WAS DETACHED AFTER LONG USE AND THE CATHETER STOPPED SPINNING. ANOTHER ULTRA ICE¿ WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH USING THE THIRD ULTRA ICE¿ DIAGNOSTIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395966 ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC DXK BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00499120 20268633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other