MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

Model Number M00546650

Device Problem Poor Quality Image (1408)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the spyscope ds ii was connected into the controller, no image was detected.Three dots came up then back to boston scientific screen.The procedure was not completed due to this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10 the returned spyglss controller was analyzed, as per sfmd report, normal wear and tear to top cover and front panel.Catheter interface contacts have unknown contamination and require replacement to repair this controller.The complaint was confirmed.A risk review confirms this is not a new or unanticipated event.As per report attached, the problem is unlikely related to manufacturing, as product analysis identified problem related to use and maintenance and did not identify any manufacturing defect.In addition, during a device history record review conducted by enercon, it was confirmed that the device met all manufacturing specifications.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.Based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Note: this report pertains to a spyscope ds ii and spy ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass digital controller were used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the spyscope ds ii was connected into the controller, no image was detected.Three dots came up then back to boston scientific screen.The procedure was not completed due to this event.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17736586
• MDR Text Key: 323284576
• Report Number: 3005099803-2023-04833
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• 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: 10/17/2023

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: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1