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

Model Number M00560150

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274); Foreign Body In Patient (2687)

Event Date 12/24/2023

Event Type  Death  

Event Description

It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2023 to treat one cratered ulcer with spurting hemorrhage found in the first portion of the duodenum.During the procedure, the area was injected with adrenaline for hemostasis and coagulation was performed successfully using the injection gold probe.For post-intervention hemostasis, hemostatic spray was deployed.There was no bleeding at the end of the procedure.On (b)(6) 2023, the patient underwent an emergent follow-up gastroscopy procedure.During the procedure, a cratered gastric ulcer with oozing hemorrhage was found at the pylorus.This was a new ulcer compared to the gastroscopy on (b)(6) 2023.The tip of the injection gold probe from the procedure on (b)(6) 2023 was discovered in the patient and in the physician's assessment was that the detached tip was possibly the cause of the new ulcer.The injection gold probe tip was retrieved with rat-tooth forceps and removed from the patient.Three hemostatic clips were successfully placed over the ulcer and there was no bleeding at the end of the follow-up procedure.The patient died on (b)(6) 2023.It is unknown what the official cause of death is at this time.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.

• Brand Name: INJECTION GOLD PROBE
• Type of Device: 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: 18640939
• MDR Text Key: 334555006
• Report Number: 3005099803-2024-00096
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0031661158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death