MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INJECTION GOLD PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00560150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during a gastroscopy procedure on (b)(6) 2025.During the procedure, the distal gold tip detached from the catheter into the patient.The tip was not removed and was left in the patient to pass naturally.The procedure was successfully completed using another injection gold probe.There were no reported patient complications resulting from this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: imdrf device code a0501 captures the reportable event of distal gold tip detached.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h2: physician's emaill address has been updated based on the additional information received on september 28, 2025.Block h6: imdrf device code a0501 captures the reportable event of distal gold tip detached.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during a gastroscopy procedure on (b)(6) 2025.During the procedure, the distal gold tip detached from the catheter into the patient.The tip was not removed and was left in the patient to pass naturally.The procedure was successfully completed using another injection gold probe.There were no reported patient complications resulting from this event.

• Brand Name: INJECTION GOLD PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 22288281
• Report Number: 3005099803-2025-02770
• Device Sequence Number: 12980640
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133933
• 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): 10/22/2025

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: M00560150
• Device Catalogue Number: M00560150
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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