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

Model Number	M00560150
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	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, the entire distal gold tip detached from the end of the catheter and fell into the patient.The distal gold tip was retrieved, and another same device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment of device or device component.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment of device or device component.Block h11: the returned trapezoid rx device was received and evaluated.Visual examination identified multiple kinks along the working length.In addition, visual and microscopic inspection confirmed that the gold distal tip was fully detached.Evidence of adhesive was observed on the catheter.The reported event is considered confirmed based on the condition of the returned device.The multiple kinks observed along the working length are consistent with excessive bending, torsion, or manipulation during use.Such deformation can compromise the structural integrity of the device.Given the presence of significant kinking, it is plausible that mechanical stress contributed to weakening of the distal assembly and subsequent detachment of the gold tip.However, a definitive sequence of failure cannot be conclusively established.Based on the available evidence, the working length deformation and distal tip detachment are most consistent with procedural handling factors.Therefore, the failure modes "working length kinked" and "distal tip detachment of device or device component" are classified as adverse event related to procedure.Regarding the reported impact code of "unexpected medical intervention," there is insufficient information available to establish a direct causal relationship between the device condition and the reported clinical outcome.Accordingly, this impact code is classified as cause not established.Based on the overall investigation findings, the most probable cause of the reported event is determined to be adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, the entire distal gold tip detached from the end of the catheter and fell into the patient.The distal gold tip was retrieved, and another same device was used to complete the procedure.There were no patient complications 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: 23607548
• Report Number: 3005099803-2025-06097
• Device Sequence Number: 15914798
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)270225(10)35935634
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0035935634
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female