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	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the stomach during a hemostasis oesophagogastroduodenoscopy (ogds) procedure performed on (b)(6) 2021.During the procedure, the tip of the gold probe detached from the catheter and fell into the patient.The tip was removed using a roth net.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of distal tip detached.Block h10: investigation results: the returned gold probe was analyzed, a visual evaluation was performed and observed that the distal tip was detached from the catheter and was not returned.The distal part of the catheter received had evidence of adhesive.No other issues were noted.Based on all available information and the condition of the returned device, the distal tip detaching from the catheter most likely occurred as a result of force applied to the device, user technique, handling and severe manipulation while trying to be used.Evidence of adhesive was noted on the catheter, which ensures that the components were once attached.The investigation concluded the most probable cause of the analyzed failure is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the stomach during a hemostasis oesophagogastroduodenoscopy (ogds) procedure performed on (b)(6) 2021.During the procedure, the tip of the gold probe detached from the catheter and fell into the patient.The tip was removed using a roth net.The procedure was completed with another gold probe.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
• MDR Report Key: 11675251
• Report Number: 3005099803-2021-01629
• Device Sequence Number: 3570732
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: 08714729174691
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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 Expiration Date: 10/30/2022
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 0026268922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74