MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problems Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Note: this report pertains to a spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on (b)(6) 2022.During preparation, the port of the controller was not functional when the connection cable from the spyscope was plug.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

Event Description

Note: this report pertains to a spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on (b)(6) 2022.During preparation, the port of the controller was not functional when the connection cable from the spyscope was plug.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.Additional information was received on november 21, 2022: it was reported that the spyscope ds ii has been used and tested with another controller and worked as intended.It was also reported that the spyglass ds controller light function did not work, and the light button would not turn on.

Manufacturer Narrative

Block h10: it was reported that the spyscope ds ii has been used and tested with another controller and worked as intended.The aborted procedure is captured under mdr# 3005099803-2022-06489.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15789475
• MDR Text Key: 307806788
• Report Number: 3005099803-2022-06655
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1