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

Model Number	M00560070
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	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to two of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-05330 for the first gold probe.It was reported to boston scientific corporation that a gold probe was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, the tip of the gold probe snapped off.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 08/01/2025 as no event date was reported.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2025 as no event date was reported.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Block h11: investigation results a gold probe was received for analysis.Media analysis revealed that the gold tip was fully detached and the catheter had evidence of adhesive.Also, it was found that the working length was kinked.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.On the other hand, it was found that the working length was kinked.This failure likely occurred due to the manner in which the device was handled and manipulated, which may have caused the condition found.Excessive manipulation of the device without sufficient care could have induced the defect identified.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
Note: this report pertains to two of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-05330 for the first gold probe, and 3005099803-2025-05331 for the second gold probe.It was reported to boston scientific corporation that a gold probe was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, the tip of the gold probe snapped off.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: 23321523
• Report Number: 3005099803-2025-05331
• Device Sequence Number: 21309622
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: (01)08714729174691(17)270326(10)36159489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: M00560070
• Device Catalogue Number: M00560070
• Device Lot Number: 0036159489
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White