BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ RX

    MDR report key: 7659741 · Received July 3, 2018

    Report

    Report Number
    3005099803-2018-02173
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 7, 2018
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K172520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONLY THE RX TUNNEL/BLACK SLEEVE WAS RETURNED FOR ANALYSIS; THE CATHETER AND BALLOON OF THE DEVICE WERE NOT RETURNED. A VISUAL EXAMINATION OF THE RX TUNNEL/BLACK SLEEVE FOUND SQUASHED AND WERE KINKED IN SEVERAL LOCATIONS. BASED ON THE INVESTIGATION PERFORMED, THE FAILURE REPORTED MAY BE RELATED TO USER ERROR. THE DIRECTIONS FOR USE (DFU) STATES THAT THE CRE RX BILIARY BALLOON DILATATION CATHETER IS DESIGNED TO PASS THROUGH AN ENDOSCOPE WITH A MINIMUM 3.7 MM WORKING CHANNEL; ALSO, THE DFU RECOMMENDS DO NOT ADVANCE THE CATHETER IF RESISTANCE IS FELT AND ALSO, IT INDICATES TO CHECK WHAT IS CAUSING THE RESISTANCE AND TAKING REMEDIAL ACTION; IF EXCESSIVE FORCE IS APPLIED TO THE DEVICE, IT COULD INDUCED DAMAGES TO BODY TISSUE, THE CATHETER, OR THE ENDOSCOPE. HOWEVER, THE CUSTOMER USED AN OLYMPUS SCOPE, GIF-Q-160 WITH A 2.8 MM WORKING CHANNEL LEADING TO THE RESISTANCE IN ADVANCING THE SCOPE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL; THE DFU STATES THAT THE CRE RX BILIARY BALLOON DILATATION CATHETER IS DESIGNED TO PASS THROUGH AN ENDOSCOPE WITH A MINIMUM 3.7 MM WORKING CHANNEL. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO EVENTS WITH THE SAME CRE RX DEVICE. MANUFACTURER REPORT# 3005099803-2018-02173 PERTAINS TO THE FIRST EVENT ON (B)(6) 2018, AND MANUFACTURER REPORT# 3005099803-2018-02174 PERTAINS TO THE SECOND EVENT ON (B)(6) 2018. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED TO DILATE THE DUODENUM PRIOR TO A BILIARY PROCEDURE ON (B)(6) 2018. DILATION WAS SUCCESSFULLY PERFORMED AND DURING THE CATHETER WITHDRAWAL, THE BLACK RX TUNNEL UNKNOWINGLY DETACHED INTO THE SCOPE. THE PROCEDURE WAS COMPLETED AT THIS TIME, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. WHEN REPROCESSING THE SCOPE, RESISTANCE WAS FELT WHEN INSERTING THE CLEANING BRUSH, BUT THE BRUSH WAS ABLE TO PASS AFTER SEVERAL TRIES. ACCORDING TO THE COMPLAINANT, A GASTROSCOPY PROCEDURE WAS PERFORMED ON (B)(6) 2018 USING THE SAME SCOPE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN INSERTING BIOPSY FORCEPS; THE BLACK RX TUNNEL WAS DISCOVERED TO BE INSIDE THE SCOPE AND WAS EXITING THE SCOPE INTO THE PATIENT. THE SCOPE WAS THEN WITHDRAWN WITH THE BLACK RX TUNNEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE.

    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. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO EVENTS WITH THE SAME CRE RX DEVICE. MANUFACTURER REPORT# 3005099803-2018-02173 PERTAINS TO THE FIRST EVENT ON (B)(6) 2018, AND MANUFACTURER REPORT# 3005099803-2018-02174 PERTAINS TO THE SECOND EVENT ON (B)(6) 2018. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED TO DILATE THE DUODENUM PRIOR TO A BILIARY PROCEDURE ON (B)(6) 2018. DILATION WAS SUCCESSFULLY PERFORMED AND DURING THE CATHETER WITHDRAWAL, THE BLACK RX TUNNEL UNKNOWINGLY DETACHED INTO THE SCOPE. THE PROCEDURE WAS COMPLETED AT THIS TIME, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. WHEN REPROCESSING THE SCOPE, RESISTANCE WAS FELT WHEN INSERTING THE CLEANING BRUSH, BUT THE BRUSH WAS ABLE TO PASS AFTER SEVERAL TRIES. ACCORDING TO THE COMPLAINANT, A GASTROSCOPY PROCEDURE WAS PERFORMED ON (B)(6) 2018 USING THE SAME SCOPE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN INSERTING BIOPSY FORCEPS; THE BLACK RX TUNNEL WAS DISCOVERED TO BE INSIDE THE SCOPE AND WAS EXITING THE SCOPE INTO THE PATIENT. THE SCOPE WAS THEN WITHDRAWN WITH THE BLACK RX TUNNEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502047 CRE¿ RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00558900 21566853

    Patients

    Seq Age Sex Outcome Treatment
    1