BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? SR PRO

    MDR report key: 3163105 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04506
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).. DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION OF THE RETURNED DEVICE REVEALED AN IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY. NO KINKS WERE OBSERVED ALONG THE LENGTH OF THE CATHETER. THE DISTAL TIP APPEARED NORMAL AND WAS INTACT. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    A CORRECTION TO THE ORIGINALLY REPORTED INFORMATION HAS BEEN MADE: IT WAS ORIGINALLY REPORTED THAT DURING INTRAVASCULAR ULTRASOUND (IVUS), THE CATHETER BROKE. AT THE TIME OF DOVETAIL, THE CATHETER BROKE. THE CORRECTION RECEIVED IS THAT DURING AN ANGIOPLASTY, A KINK FROM THE CATHETER NEST TO THE CONNECTOR WAS OBSERVED AFTER REMOVAL OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND (IVUS), THE CATHETER BROKE. AS NOTED BY THE PHYSICIAN, A RESISTANCE WAS FELT DURING PULLBACK. AT THE TIME OF DOVETAIL, THE CATHETER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT'S CONDITION WAS GREAT.

    Description of Event or Problem · 1

    A CORRECTION TO THE ORIGINALLY REPORTED INFORMATION HAS BEEN MADE: IT WAS ORIGINALLY REPORTED THAT DURING INTRAVASCULAR ULTRASOUND (IVUS), THE CATHETER BROKE. AT THE TIME OF DOVETAIL, THE CATHETER BROKE. THE CORRECTION RECEIVED IS THAT DURING AN ANGIOPLASTY, A KINK FROM THE CATHETER NEST TO THE CONNECTOR WAS OBSERVED AFTER REMOVAL OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264362 ATLANTIS? SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749389420 15434141

    Patients

    Seq Age Sex Outcome Treatment
    1