BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6084250 · Received November 7, 2016

    Report

    Report Number
    3005099803-2016-03263
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SPYSCOPE DS DEVICE FOUND THAT THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. THE DISTAL TIP WOULD ARTICULATE WITHOUT ISSUE. THE PROXIMAL END OF THE DISTAL CAP WAS ALIGNED TO THE CAP WELD. A SPYBITE DEVICE WAS PASSED FREELY THROUGH THE WORKING CHANNEL WITHOUT ISSUE. 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. THE DISTAL END OF THE EXPOSED WORKING CHANNEL SLEEVE WAS TUGGED; IT WAS NOT DETACHED FROM THE CATHETER. 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. BASED ON THE INVESTIGATION AND THE RECEIPT CONDITION/FUNCTIONALITY, THE MOST PROBABLE ROOT CAUSE IS "MANUFACTURING". THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2016-03262 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, AND 3005099803-2016-03263 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) AND IN THE UPPER INTRAHEPATICS DURING A SPYGLASS WITH BIOPSY AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL OF THE SPYSCOPE DS WAS PROTRUDING. A SECOND SPYSCOPE DS WAS USED; HOWEVER, SAME THING HAPPENED. REPORTEDLY, NO PART OF THE DEVICES DETACHED AND NO OTHER VISIBLE DAMAGE WAS NOTED ON THE TWO SPYSCOPE DS. THE PROCEDURE WAS COMPLETED WITH A THIRD SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2016-03262 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, AND 3005099803-2016-03263 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) AND IN THE UPPER INTRAHEPATICS DURING A SPYGLASS WITH BIOPSY AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL OF THE SPYSCOPE DS WAS PROTRUDING. A SECOND SPYSCOPE DS WAS USED; HOWEVER, SAME THING HAPPENED. REPORTEDLY, NO PART OF THE DEVICES DETACHED AND NO OTHER VISIBLE DAMAGE WAS NOTED ON THE TWO SPYSCOPE DS. THE PROCEDURE WAS COMPLETED WITH A THIRD SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734151 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 19422878

    Patients

    Seq Age Sex Outcome Treatment
    1