BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6344586 · Received February 20, 2017

    Report

    Report Number
    3005099803-2017-00433
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SPYSCOPE DS DEVICE FOUND THAT THE WORKING CHANNEL SLEEVE EXTENDED WHEN RECEIVED. THE PROXIMAL END OF THE DISTAL CAP WAS ALIGNED TO THE CAP WELD. A SPYBITE DEVICE WAS PASSED THROUGH THE WORKING CHANNEL WITHOUT ISSUE. THE DISTAL END OF THE EXPOSED WORKING CHANNEL SLEEVE WAS TUGGED; IT WAS NOT DETACHED FROM THE CATHETER. THERE WAS EVIDENCE THAT HEAT WAS APPLIED ON THE OUTSIDE OF THE CATHETER DURING MANUFACTURING ASSEMBLY. PART OF THE DISTAL END OF THE CATHETER WAS REMOVED TO EXAMINE THE WORKING CHANNEL. FURTHER EVALUATION FOUND THAT THERE IS EVIDENCE OF ADHESION OF THE WORKING CHANNEL SLEEVE TO THE INSIDE OF THE CATHETER. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF WORKING CHANNEL SLEEVE PROTRUDING. MOST LIKELY, THE DEFECT WAS DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT OF THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT IS OPERATIONAL CONTEXT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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 SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125262 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 19694444 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1