MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE

Model Number	M00518151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	05/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block h6: impact code f02 captures the reportable event of death.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the esophagus during a peroral endoscopic myotomy (poem) procedure performed on (b)(6) 2023, for the treatment of achalasia.During the procedure, the patient began to present low vitals including low blood pressure and decreased pulse.It was reported that they performed cpr for around 20 minutes and the patient was transferred from the operating room to the intensive care unit where at some point they passed away.The physicians present were able to confirm that due to anesthesia error, the patient did not have access to anesthesia machine ventilation, as the ventilation tube was bent.In the physician's assessment, the interject needle device was used correctly and did not contribute to the patient's death.It was confirmed that anesthesiology error was the cause of death.There was no alleged malfunction of the interject needle.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17076034
• Report Number: 3005099803-2023-02876
• Device Sequence Number: 12430594
• Product Code: FCG
• UDI-Device Identifier: 08714729296430
• UDI-Public: 08714729296430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171454
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: M00518151
• Device Catalogue Number: 1815
• Device Lot Number: 0028241475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death; Other
• Patient Sex: Female