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

Model Number	M00560150
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	11/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: 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 was used during a procedure on (b)(6) 2024.During the procedure, the probe was passed through the gastroscope to the desired location in the upper part of the ventricle.The operator wanted to pull the needle in to retract the probe up the scope, but it became visible that the tip of probe with the needle was about to release from the rest of the probe.Instead of pulling the probe into the working channel and risking the tip detaching, the operator chose to slowly pull the entire scope back.When they reached the pharynx, about 3cm of the distal needle probe detached.The detached piece was removed with mcgills forceps, and the procedure was completed using the original device.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during procedure on (b)(6) 2024.During the procedure, the probe was passed through the gastroscope to the desired location in the upper part of the ventricle.The operator wanted to pull the needle in to retract the probe up the scope, but it became visible that the tip of probe with the needle was about to release from the rest of the probe.Instead of pulling the probe into the working channel and risking the tip detaching, the operator chose to slowly pull the entire scope back.When they reached the pharynx, about 3cm of the distal needle probe detached.The detached piece was removed with mcgills forceps, and the procedure was completed using the original device.There were no reported patient complications as a result of this event.Additional information received on december 16, 2024 the procedure was a gastroscopy, and the anatomy location was upper gi tract (esophagus and ventricle).
Additional Manufacturer Narrative
Block h2: block b5 has been updated based on the additional information received on december 16, 2024.Block h6: imdrf device code a0501 captures the reportable event of distal tip detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detached.Block h11: investigation results.The returned injection gold probe was received for analysis.Visual examination revealed that the gold tip was fully detached, the catheter, the wires and the tip have evidence of adhesive.In addition, the gold tip was found with residues from the procedure.The reported event was confirmed.Based on the available information, the investigation findings were most likely due to procedural factors such as lesion characteristics, handling of the device, the technique used by the physician.Also, the catheter and the wires had residues of adhesive indicating that the tip was correctly assembled.Therefore, a review and analysis of all available information indicated the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the upper gi tract during gastroscopy procedure on (b)(6) 2024.During the procedure, the probe was passed through the gastroscope to the desired location in the upper part of the ventricle.The operator wanted to pull the needle in to retract the probe up the scope, but it became visible that the tip of probe with the needle was about to release from the rest of the probe.Instead of pulling the probe into the working channel and risking the tip detaching, the operator chose to slowly pull the entire scope back.When they reached the pharynx, about 3cm of the distal needle probe detached.The detached piece was removed with mcgills forceps, and the procedure was completed using another injection gold probe.There were no reported patient complications 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20985528
• Report Number: 3005099803-2024-06331
• Device Sequence Number: 20943223
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: 08714729056492
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 02/20/2025

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: 06/04/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0034167825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 01/22/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/14/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown