BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE

    MDR report key: 8996448 · Received September 11, 2019

    Report

    Report Number
    3005099803-2019-04526
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 29, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729174691
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE 2907 CAPTURES THE REPORTABLE EVENT OF THE TIP OF THE NEEDLE DETACHED. INVESTIGATION RESULTS: ONE GOLD PROBE WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE TIP WAS DETACHED FROM THE CATHETER. ADDITIONALLY, THE CATHETER WAS CUT AND A BLUE STAIN WAS OBSERVED INSIDE THE CATHETER. NO OTHER ISSUES WERE NOTED. THE BLUE STAIN THAT WAS OBSERVED WITHIN THE CATHETER OF THE RETURNED DEVICE WAS ANALYZED AND PRESENTED A SPECTRAL MATCH WITH ADHESIVE MATERIALS AND CHOLESTEROL MEDICATION. THE STAIN MOST LIKELY OCCURRED AS A RESULT OF USE OF THE DEVICE DURING THE PROCEDURE. ANALYSIS RESULTS CAPTURED A 96.20% MATCH TO CASCOPHEN LT 68D, WHICH IS AN ADHESIVE, INDICATING THAT THE ADHESIVE WAS APPLIED TO THE DEVICE DURING MANUFACTURING PROCESS. THE STAIN ALSO CAPTURED A 96.50% MATCH TO COLESTIPOL HCL IN KBR (COLESTIPOL HCL IS THE GENERIC FORM OF THE BRAND-NAME DRUG COLESTID, WHICH IS USED TO TREAT HIGH CHOLESTEROL.) MOST LIKELY HANDLING AND MANIPULATION OF THE DEVICE DURING USE CONTRIBUTED TO THE EVENT OF DISTAL TIP DETACHED. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PROBE TIP DISCONNECTED FROM THE SHEATH.THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PROBE TIP DISCONNECTED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792244 GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00560070 0023198040 08714729174691

    Patients

    Seq Age Sex Outcome Treatment
    1