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	09/23/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the needle detached from the device and fell off into the patient.The detached needle was removed from the patient using a net and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: correction block b5 (anatomy location) and block e1 (email) have been corrected.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 the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.A risk review was completed and confirmed that the event of needle detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the needle detached from the device and fell off into the patient.The detached needle was removed from the patient using a net 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: 23312486
• Report Number: 3005099803-2025-05333
• Device Sequence Number: 5826873
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)270310(10)36032992
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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 Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0036032992
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 03/10/2025
• 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