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

Model Number	6007-05
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	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during a hemostasis procedure on (b)(6), 2025.During the procedure, the tip fell off in patient and get detached from the end of the catheter.It was retrieved using the net.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: correction block b5, the anatomy location was added.Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h11: investigation results- the returned gold probe was received for analysis.Visual examination revealed that the gold tip was completely detached and did not return.Additionally, the catheter and wires showed evidence of adhesive residue.The reported event was confirmed.Based on the available information, the investigation findings were most likely that procedural or anatomical factors encountered during device use may have affected its performance and integrity, leading to the detachment of the tip.This issue could have occurred due to contact between the device and the scope during energization, or if the device exceeded the maximum voltage during the procedure, as outlined in the device precautions.It is also important to note that the presence of adhesive residue on the catheter and wires indicates that the tip was correctly assembled.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the stomach during a hemostasis procedure on (b)(6) 2025.During the procedure, the tip fell off in patient and get detached from the end of the catheter.It was retrieved using the net.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.

• Brand Name: 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: 22993111
• Report Number: 3005099803-2025-04283
• Device Sequence Number: 9468844
• Product Code: KNS
• UDI-Device Identifier: 08714729071013
• UDI-Public: (01)08714729071013(17)270528(10)36625675
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K970278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 6007-05
• Device Catalogue Number: 6007-05
• Device Lot Number: 0036625675
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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