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

Model Number M00546650

Device Problems Connection Problem (2900); Appropriate Term/Code Not Available (3191)

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

Event Date 05/14/2021

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 two spyscope ds ii access & delivery catheters and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters and a spyglass ds controller were used during a common bile duct (cbd) lithotripsy procedure performed on (b)(6) 2021.During the procedure, a spyscope ds ii was not recognized when inserted it into the controller.The controller was rebooted and reconnected to the spyscope ds ii several times, but the attempts were unsuccessful.A second spyscope ds ii was used and the same problem occurred.The procedure was not completed due to this event.A plastic stent was placed and the procedure was rescheduled.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to two spyscope ds ii access & delivery catheters and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii access & delivery catheters and a spyglass ds controller were used during a common bile duct (cbd) lithotripsy procedure performed on (b)(6) 2021.During the procedure, a spyscope ds ii was not recognized when inserted it into the controller.The controller was rebooted and reconnected to the spyscope ds ii several times, but the attempts were unsuccessful.A second spyscope ds ii was used and the same problem occurred.The procedure was not completed due to this event.A plastic stent was placed and the procedure was rescheduled.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a27 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 no defects, wear and tear or damaged.A functional evaluation noted that there were no functional problems found.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.Upgraded firmware to v2.2.Light engine calibration was performed and a test was ran.An electrical safety test was performed and the unit passed all tests.The reported event was not confirmed.Upon analysis, there were no functional problems found.A risk review found that the connection problem is an expected risk detailed in the risk documentation.During a device history record review conducted by enercon it was confirmed that the device met all manufacturing specifications.Based on all gathered information, the most probable root cause of this event is no problem detected.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.

• 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: 11990710
• MDR Text Key: 255921078
• Report Number: 3005099803-2021-02825
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1