MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE

Model Number	M00518250
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the needle detached from the sheath.Another interject needle was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the needle detached from the sheath.
Additional Manufacturer Narrative
Block g4: additional premarket / 510(k) #: k171454.Block h6: imdrf device code a0501 captures the reportable event of the needle detached from the sheath.Block h11: the device was not returned, however, media analysis found that the handle detached.Based on all available information, the product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the needle detached from the sheath.Another interject needle was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE
• 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: 22088046
• Report Number: 3005099803-2025-02325
• Device Sequence Number: 20569878
• Product Code: FCG
• UDI-Device Identifier: 08714729415091
• UDI-Public: (01)08714729415091(17)270610(10)34205937
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K012864
• 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): 06/18/2025

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 Model Number: M00518250
• Device Catalogue Number: M00518250
• Device Lot Number: 0034205937
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 06/10/2024
• 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: Unknown