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

Model Number	M00560070
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	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gold probe hemostatis catheter was used in the during a gastrointestinal procedure performed on (b)(6) 2021.During the procedure, the gold probe needle was removed from the packaging to treat the patient.Upon removal, the device tip fell off and on to the floor.The procedure was completed with another gold probe hemostatis catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
This event was reported by a hospital supply chain employee.The reported physician is: (b)(6).(b)(4).(product investigation): one gold probe was received for analysis and a visual inspection noted that the tip of the device was detached.A microscope inspection revealed that the distal end of the catheter had evidence that the tip was correctly attached at one point.Evidence of tension was also observed on the wires end.No other issues were noted.The reported event was confirmed.Based on the information available and the analysis performed, it's most likely that user manipulation and/or some technique while unpacking or preparing the device resulted in submitting some extra tension to the tip which lead to the distal tip detaching.Therefore, the most probable root cause for this problem is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12919099
• Report Number: 3005099803-2021-05940
• Device Sequence Number: 4983249
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 07/01/2023
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0027595350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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