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

Model Number	M00555580
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b pro code (product code): additional pro code: odg block h6: device code a041001 is being used to capture the reportable event of needle punctured sheath.Device code a0501is being used to capture the reportable event of needle detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fnb needle 19 g flex was used for an endoscopic ultrasound (eus) procedure performed on (b)(6) 2026.During the procedure, the needle would not extend out of the sheath.When the device was trying to be removed from the scope, the needle broke and detached from the device.While the device was taking out of the scope, the needle caused damaged to the scope and punctured the sheath.Another acquire eus fnb needle 19 g flex was used to successfully continue and complete the procedure.There was no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25256608
• Report Number: 3005099803-2026-02028
• Device Sequence Number: 5496144
• Product Code: FCG
• UDI-Device Identifier: 08714729931829
• UDI-Public: (01)08714729931829(17)281215(10)38541306
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K223616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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 Model Number: M00555580
• Device Catalogue Number: M00555580
• Device Lot Number: 0038541306
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 12/16/2025
• 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