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

Model Number	M00555540
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product code) is odg; reported here as pro codes (product codes) exceeded character limit for designated field.Block e1: initial reported address: (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used during an echo-endo procedure on (b)(6) 2024.According to the complainant, the procedure was canceled while using the device.Due to this event, the patient's hospital stay was prolonged.

• Brand Name: ACQUIRE
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22039017
• Report Number: 3005099803-2025-01870
• Device Sequence Number: 18396588
• Product Code: FCG
• UDI-Device Identifier: 08714729931782
• UDI-Public: (01)08714729931782(17)260802(10)32147325
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K160845
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 08/02/2026
• Device Model Number: M00555540
• Device Catalogue Number: M00555540
• Device Lot Number: 0032147325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 08/03/2023
• 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