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

Model Number M00546610

Device Problem Poor Quality Image (1408)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangeopancreatography (ercp) and spyglass procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was flickering and choppy throughout the case.The spyscope ds ii was unplugged and replugged into the spyglass ds controller.The controller was shut down and restarted, however, the image was not sufficient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangeopancreatography (ercp) and spyglass procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was flickering and choppy throughout the case.The spyscope ds ii was unplugged and replugged into the spyglass ds controller.The controller was shut down and restarted, however, the image was not sufficient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on july 27, 2023: it was reported that the controller has been tested since this event and worked as intended.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.

• 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: 17386149
• MDR Text Key: 319763284
• Report Number: 3005099803-2023-03980
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/18/2023
• 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