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 12/17/2020

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 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, while they were into the common bile duct, the image of the spyscope ds ii disappeared immediately for several times while they were into the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

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 an endoscopic retrograde cholangiopancreatograhy (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, while they were into the common bile duct, the image of the spyscope ds ii disappeared immediately for several times while they were 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

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 top cover had a finish damage.A functional evaluation noted no functional problems other than the light engine required cleaning and calibration.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.All hardware items were re-torqued as needed.Light engine calibration was performed and tests were ran.Electrical safety tests were also performed.The unit passed all tests.The labels were also replaced.Per media analysis, the pictures showed and confirmed the loss of visualization problem.No other problems were noted.Per the evaluation conducted by enercon technologies, the reported event could not be duplicated.Per enercon technology's analysis, there were no functional problems noted other than the light engine that required cleaning and calibration.However, visual inspection was performed by boston scientific, and the reported event of loss of visualization was confirmed.These investigation findings suggest that the problem presented was intermittent, and it is likely that procedural factors could have caused the reported event.A risk review confirms this is not a new or unanticipated event.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 adverse event related to procedure.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: 11131297
• MDR Text Key: 225537212
• Report Number: 3005099803-2020-06459
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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: 06/08/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1