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

Model Number	M00560160
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	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Imdrf device code a0501 captures the reportable event of distal tip detached.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe needle was used during a gastroscopy procedure performed on an unknown date.During the procedure, the distal gold tip of the needle detached and fell into the patent's stomach.A rat tooth forceps was used to retrieve the detached distal gold tip and the procedure was completed with a similar injection gold probe needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of distal tip detached.Block h10: investigation results.One injection gold probe was received for analysis.Media analysis of the returned device found the tip was detached.Visual analysis of the returned device found the tip was detached from the catheter and the working length was kinked.No other device problems were noted.The reported event of "distal tip detached" is confirmed since the distal tip was detached.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found the distal tip was detached and the working length was kinked during visual and media tests.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is adverse event related to procedure.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe needle was used during a gastroscopy procedure performed on an unknown date.During the procedure, the distal gold tip of the needle detached and fell into the patent's stomach.A rat tooth forceps was used to retrieve the detached distal gold tip and the procedure was completed with a similar injection gold probe needle.There were no patient complications reported as a result of this event.

• Brand Name: INJECTION 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16554799
• Report Number: 3005099803-2023-01022
• Device Sequence Number: 4991369
• Product Code: KNS
• UDI-Device Identifier: 08714729056508
• UDI-Public: 08714729056508
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 06/26/2024
• Device Model Number: M00560160
• Device Catalogue Number: 6016
• Device Lot Number: 0029664477
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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