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

Model Number M00546650

Device Problems Poor Quality Image (1408); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct on (b)(6) 2021.During the procedure, the spyglass unit was displaying artifacts on the screen.When these artifacts are being encountered, the 5 green dots appeared to be flashing again like the connection is being reestablished.The procedure was not completed and rescheduled.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct on october 08, 2021.During the procedure, the spyglass unit was displaying artifacts on the screen.When these artifacts are being encountered, the 5 green dots appeared to be flashing again like the connection is being reestablished.The procedure was not completed and rescheduled.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass ds digital controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover and front panel had finish damage.A functional evaluation noted that both y/c video output connectors were physically damaged.The catheter interface contacts was contaminated with unknown material.Both of these situations, separately or combined, could have caused the customer described issue and could be attributed to maintenance of the controller.The reported event 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 problems 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 most probable root cause is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.Block h11: correction - block h6 (impact code and device code) has been corrected.

• 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: 12751022
• MDR Text Key: 280096820
• Report Number: 3005099803-2021-05752
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• 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