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

Model Number	M00560071
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	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was i the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician used a gold probe to control bleeding.When the device was removed from the scope, the tip was cleaned off and detached from the catheter.Another gold probe was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment.Block h11: investigation results: the returned gold probe device was analyzed, and visual and microscopic evaluation found that the gold tip was fully detached from the catheter and had residues from the procedure.Additionally, the catheter and the wires had evidence of adhesives, and the working length was kinked and jammed at several sections.The reported event was confirmed.The kinked and jammed working length could be due to excess manipulation and possible excess force applied to the device.The gold tip was fully detached from the catheter, most likely due to procedural or anatomical factors during the use of the device.These could have affected the device performance and integrity, causing the detachment of the tip.Also, the tip detachment could have been generated if there was contact between the device and the scope during energization, or if the device exceeded its maximum voltage during the procedure as per precautions of the device states.Based on all available information, adverse event related to procedure was selected as the most probable cause.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician used a gold probe to control bleeding.When the device was removed from the scope, the tip was cleaned off and detached from the catheter.Another gold probe was used to complete the procedure.There were no patient complications reported 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19838105
• Report Number: 3005099803-2024-03545
• Device Sequence Number: 7594890
• Product Code: KNS
• UDI-Device Identifier: 08714729071013
• UDI-Public: 08714729071013
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/11/2024

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: 03/15/2026
• Device Model Number: M00560071
• Device Catalogue Number: 6007-05
• Device Lot Number: 0033636824
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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