MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL SNARE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	M00546560
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(expiration date): the device was expired on february 26, 2021, but the device was used during a procedure on (b)(6) 2021.(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 or Problem Description
Note: this report pertains to the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS RETRIEVAL SNARE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11633975
• Report Number: 3005099803-2021-01573
• Device Sequence Number: 3547216
• Product Code: PTS
• UDI-Device Identifier: 08714729965893
• UDI-Public: 08714729965893
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: M00546560
• Device Catalogue Number: 4656
• Device Lot Number: 0023409381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1