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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of distal tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe needle was used in the lungs during a bronchoscopy procedure performed on (b)(6)2023.During preparation, the entire gold tip detached from the end of the catheter when the needle tip was being cleaned.The procedure was completed with an alternative device.It is unknown if another of the same device was used or a different device.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 detached.Block h10: investigation results the returned gold probe needle was analyzed.The visual evaluation found that the tip was returned detached from the working length.In addition, the working length bent in different sections.No other problems were noted.The reported event was confirmed.Product analysis identified that the tip was returned detached from the working length (still attached to the device) and working length was bent in different sections.Most likely the manner that the device was manipulated could have resulted in the detachment of the tip.Also, it is possible that procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied) could have cause the bents encountered in the working length.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.According to the information provided, it was reported that the gold probe was used in a pulmonary case (airway/lungs).However, as per the ifu, this device is indicated for the endoscopy procedure.For this reason, this event is cataloged as "cause traced to intentional off-label, unapproved, or contraindicated use" because the problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe needle was used in the lungs during a bronchoscopy procedure performed on april 26, 2023.During preparation, the entire gold tip detached from the end of the catheter when the needle tip was being cleaned.The procedure was completed with an alternative device.It is unknown if another of the same device was used or a different device.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: 16966180
• Report Number: 3005099803-2023-02578
• Device Sequence Number: 14800805
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/26/2023

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: 01/22/2025
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0030903297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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