MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYBITE MAX; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00546470
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forcep was used in the hepatic bile duct during a percutaneous transhepatic cholangiography (ptc) with the spyglass procedure for a biopsy on (b)(6) 2025.During the procedure, after the spybite biopsy forcep was inserted and opened, the device did not close to take a biopsy sample.The device was removed, and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of procedure not completed.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22328075
• Report Number: 3005099803-2025-02860
• Device Sequence Number: 20935306
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: (01)08714729996699(17)250623(10)29651922
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 06/25/2025

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: 06/23/2025
• Device Model Number: M00546470
• Device Catalogue Number: M00546470
• Device Lot Number: 0029651922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2025
• Initial Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 06/24/2022
• 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 Sex: Female