MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	1830
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	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used during a gastric varices procedure performed on (b)(6) 2025.Upon unpacking, the needle was broken and detached.It is unknown how the procedure was completed; however, it was reported to have been successfully completed there were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used during a gastric varices procedure performed on (b)(6) 2025.Upon unpacking, the needle was broken and detached.It is unknown how the procedure was completed; however, it was reported to have been successfully completed there were no reported patient complications as a result of this event.Additional information was received on november 24, 2025: the procedure was completed with another interject needle.
Additional Manufacturer Narrative
Block e1: initial reporter facility name, address, and city: (b)(6).Block h2: additional information: block b5 has been updated based on the additional information received on november 24, 2025.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.

• Brand Name: INTERJECT
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23582291
• Report Number: 3005099803-2025-05967
• Device Sequence Number: 15797226
• Product Code: FBK
• UDI-Device Identifier: 08714729296508
• UDI-Public: (01)08714729296508(17)260803(10)32152693
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171454
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 08/03/2026
• Device Model Number: 1830
• Device Catalogue Number: 1830
• Device Lot Number: 0032152693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 05/09/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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