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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2025.During the procedure, the device broke down and the tip of the device remained inside the duodenum of the patient.The tip of the device was retrieved using a basket and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of distal tip detachment of device or device component imdrf impact code f2301 is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2025.During the procedure, the device broke down and the tip of the device remained inside the duodenum of the patient.The tip of the device was retrieved using a basket and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: device code a0501 captures the reportable event of distal tip detachment of device or device component.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.H11: investigation results: the injection gold probe was not returned, however, the customer provided picture where it was possible to observe that the gold tip was fully detached.The reported event was confirmed.Based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After media analysis it was observed that the tip was detached, however, the most probable cause of the reported issues cannot be established due to lack of evidence.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.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of distal tip detachment of device or device component imdrf impact code f2301 is being used to capture the reportable event of additional device required.Block h11: investigation results an injection gold probe was received for analysis.Visual examination of the returned device revealed that the gold tip was fully detached, the catheter had few traces of adhesive.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.The reported event was confirmed.Based on the available information, it was concluded that the manufacturing process was capable of ensuring the correct assembly of the tip.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 injection gold probe was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2025.During the procedure, the device broke down and the tip of the device remained inside the duodenum of the patient.The tip of the device was retrieved using a basket and completed the procedure.There were no patient complications reported as a result of 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: 22958028
• Report Number: 3005099803-2025-04281
• Device Sequence Number: 15850837
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)261002(10)34978787
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 10/02/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0034978787
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 11/24/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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