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

Model Number	M00546650
Medical Device Problem Codes	Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number for the spy ds controller, 3005099803-2024-02822 for the first spyscope, and 3005099803-2024-02823 for the second spyscope.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheters and a spy ds controller were attempted for use in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of hilar stenosis on (b)(6) 2024.During preparation for the procedure, there was difficulty plugging the spyscope umbilicus connector into the controller.They made two unsuccessful attempts with two different spyscopes.The procedure was not able to be completed as a result of this event.It was rescheduled and completed using another spy ds controller and spyscope on (b)(6) 2024.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block h10: investigation results the returned spy ds controller was analyzed.The front panel was cracked.The controller housing and front panel were knocked out of alignment due to impact damage.The impact also caused damage to the catheter interface printed circuit board (pcb).The reported clinical observation was confirmed.Based on all gathered information, the conclusion code selected for this event is cause traced to component failure, which indicates expected or random component failures identified without any design or manufacturing problem.It is likely that damage to the controller affected the device performance and integrity, leading to the events experienced by the customer.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-02824 for the spy ds controller, 3005099803-2024-02822 for the first spyscope, and 3005099803-2024-02823 for the second spyscope.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheters and a spy ds controller were attempted for use in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of hilar stenosis on (b)(6) 2024.During preparation for the procedure, there was difficulty plugging the spyscope umbilicus connector into the controller.They made two unsuccessful attempts with two different spyscopes.The procedure was not able to be completed as a result of this event.It was rescheduled and completed using another spy ds controller and spyscope on (b)(6) 2024.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DS
• Common Device Name: 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: 19519954
• Report Number: 3005099803-2024-02824
• Device Sequence Number: 20895832
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Device Lot Number: 2308700078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown