MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546610
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii was used during a spyglass assisted common bile duct (cbd) stone extraction with laser procedure performed on (b)(6) 2022.During the procedure, it was noticed that the sheath of the spyscope ds ii peeled off from one side during introduction and it was removed immediately from the working channel of the duodenoscope.It was reported that no part was detached inside the patient.The procedure was not completed due to same device unavailable and the physician's planned to reschedule the procedure after 2 weeks.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii was used during a spyglass assisted common bile duct stone extraction with laser procedure performed on (b)(6) 2022.During the procedure, it was noticed that the sheath of the spyscope ds ii peeled off from one side during introduction and it was removed immediately from the working channel of the duodenoscope.It was reported that no part was detached inside the patient.The procedure was not completed due to same device unavailable and the physician's planned to reschedule the procedure after 2 weeks.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were elevator marks on the shaft of the catheter.Visual inspection of the external shaft at the distal end of the device showed damage in the form of a small tear and peeling of the light-blue layer of polytetrafluoroethylene (ptfe).The handle was opened, and the breakout region of the handle was visually inspected.There was procedural residue seen in the plastic optic fibers (pof) indicating that the device was used.The reported complaint regarding device damaged/defective was confirmed.During product analysis, signs of use in the form of witness marks and procedural residue at the pofs were noted.Visual inspection of the external shaft at the distal end confirmed damaged in the form of a small tear and peeling of the light-blue layer of ptfe.Based on the presence and location of the damage to the external shaft, it is likely that interaction with the combination device (i.E., duodenoscope) led to the observed tear and peeling of the external ptfe.Based on the event description, the damage to the sheath was observed after the catheter was fed through the duodenoscope, which likely means the external shaft of the catheter was damaged as the catheter was being inserted through the combination device.Based on all gathered information, the probable cause selected for the reported problem is adverse event related to procedure, which indicates that the device complaint or problem occurred during the procedure and the device had no influence on event.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16109418
• Report Number: 3005099803-2022-07992
• Device Sequence Number: 16537127
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Expiration Date: 01/06/2024
• Device Model Number: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0028636389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female