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

Model Number	M00546270
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forceps was used in the wirsung pancreas during an exploration with discover spyglass procedure performed on (b)(6), 2023.During the procedure, the forceps failed to close on the fourth sample attempt.The catheter was cut, and the forceps were removed from the working channel of the scope.The forceps did not collect a sufficient sample and there were no more biopsy forceps available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spybite biopsy forceps was analyzed, and a visual evaluation noted that the jaws were not returned, it was cut from the jacket.Additionally, it was found that the jacket and pull wire were returned unraveled with evidence of a mechanical cut.No other issues were noted.The reported event was not confirmed.Based on all available information, it is most likely procedural factors as lesion characteristics, handling of the device, or the technique used by the physician could have caused the physician to cut the device during the procedure.Therefore, the most probable root cause is adverse event related to procedure.Furthermore, the exact cause of the jaws failing to close on the device is uncertain due to the lack of a proper evaluation as the jaws were not returned.The investigation did not provide a clear conclusion, so "cause not established" is chosen as the likely cause for the reported event of jaws failure to close.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
It was reported to boston scientific corporation that a spybite biopsy forceps was used in the wirsung pancreas during an exploration with discover spyglass procedure performed on (b)(6) 2023.During the procedure, the forceps failed to close on the fourth sample attempt.The catheter was cut, and the forceps were removed from the working channel of the scope.The forceps did not collect a sufficient sample and there were no more biopsy forceps available; therefore, the procedure was aborted.There were no patient complications reported as a result of this event.

• Brand Name: SPYBITE
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16967298
• Report Number: 3005099803-2023-02558
• Device Sequence Number: 17537875
• Product Code: FCL
• UDI-Device Identifier: 08714729764458
• UDI-Public: 08714729764458
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 10/19/2025
• Device Model Number: M00546270
• Device Catalogue Number: 4627
• Device Lot Number: 0030386694
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: 68 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG