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

Device Problem Difficult to Advance (2920)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the device brand name, upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

Note: this report pertains to a spybasket, two spyscope ds ii access, & autolith touch ehl probes that were used in the same patient and procedure.It was reported to boston scientific corporation that a spybasket was used in the biliary tract during a lithotripsy procedure performed on (b)(6) 2022.During the procedure, while in the patient's biliary tract using the autolith probe to break up the stones, there was interference with the image on the monitor.After a few moments the interference subsided and an attempt was made to insert the spyglass retrieval basket, but it did not pass through the working channel.It was abandoned after several attempts.The autolith probe also began to present resistance when passing through the working channel.Around the thirtieth hour of the procedure, the transmission was interrupted on the screen monitor and only the three gray dots indicating timeout were visible.From that moment on, the image was completely lost.A second spyscope was connected but did not transmit any image.After a few troubleshooting, alternating the spyscopes the images were not restored.The procedure was not completed due to this event.There were no patient complications reported as a result after this event.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16118758
• MDR Text Key: 308617049
• Report Number: 3005099803-2023-00016
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male