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

Model Number M00546650

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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 mdr will be filed.

Event Description

Note: this report pertains to a spyscope ds ii access and delivery catheter and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used with a spyglass ds controller during a bile duct drainage procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, while performing angle manipulation, the image of the spyscope ds ii disappeared about 20 minutes into the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(6).Block h6 (device codes): problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass digital controller was analyzed by enercon technologies, and a visual evaluation noted that the controller had minor finish damage to the covers and front panel.A functional evaluation noted that the catheter interface contacts were dirty and in need of cleaning and calibration.This could possibly be the cause of the reported problem.The error log was checked, and an error accessing a peripheral device was noted and could suggest a scope problem.The light engine was disassembled.The catheter interface contacts and the connector socket assembly were cleaned.Secure grounds and connections were verified.Light engine calibration and tests were performed, including an electrical safety test.The unit passed all tests.The reported event of loss of visualization was not confirmed.Upon analysis, the controller had minor finish damage to covers and front panel.Additionally, the catheter interface contacts were dirty and in need of cleaning and calibration which could be a possible cause of the reported problem.The error, error accessing a peripheral device, could also suggest a scope problem.Handling during use and reprocessing over time likely contributed to the event.Based on all gathered information, the conclusion code selected for this event is cause traced to 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.

Event Description

Note: this report pertains to a spyscope ds ii access and delivery catheter and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used with a spyglass ds controller during a bile duct drainage procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, while performing angle manipulation, the image of the spyscope ds ii disappeared about 20 minutes into the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of 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
• MDR Report Key: 11065431
• MDR Text Key: 226304618
• Report Number: 3005099803-2020-06317
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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: 01/13/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1