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

Model Number	M00560070
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during a bronchoscopy procedure to control bleeding on a unkown date in (b)(6) 2024.When the device was removed from the bronchoscope, the tip of the gold probe was missing.The bronchoscope was reinserted into the patient and the broken tip was visualized.The detach tip was retrieved using the suction from the scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of distal tip detached.Block b3: exact date unknown, event occurred in (b)(6) 2024.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of distal tip detached.Block b3: exact date unknown, event occurred in may 2024.Information from blocks b5, e1 and h6 have been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during a bronchoscopy procedure to control bleeding on an unknown date in (b)(6) 2024.When the device was removed from the bronchoscope, the tip of the gold probe was missing.The bronchoscope was reinserted into the patient and the broken tip was visualized.The detach tip was retrieved using the suction from the scope.There were no patient complications reported as a result of this event.Note: the device was reported to be used during a bronchoscopy procedure; however, the ifu does not list this anatomy as an indication.The gold probe ifu states, "the gold probe catheter and the gold probe 350cm catheter are indicated for use in transendoscopic electrohemostasis of visible bleeding and non-bleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon".

• 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: 20196894
• Report Number: 3005099803-2024-04155
• Device Sequence Number: 12466348
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 01/31/2026
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0033340151
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White