MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555580
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic ultrasound-guided liver biopsy performed on (b)(6) 2023.During the procedure, the needle did not extend.It was found that the needle was disengaged from the handle.Additionally, it was confirmed that the distal needle tip detached from the device, however the tip did not fall inside the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle distal tip detachment.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the liver during an endoscopic ultrasound-guided liver biopsy performed on (b)(6) 2023.During the procedure, the needle did not extend.It was found that the needle was disengaged from the handle.Additionally, it was confirmed that the distal needle tip detached from the device, however the tip did not fall inside the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle distal tip detachment.Block h11: the returned acquire eus fnb needle was analyzed, and visual inspection found no visible damages.A functional test found the needle was able to extend and retract as intended, and the tip was not detached.A video was provided by the customer that showed the device being tested outside the patient and the needle was not extending.The reported event "needle failure to extend" and "distal tip detachment of device or device component" was not confirmed.Since it was determined that the device did not have any visual issues/damages, the needle was able to extend and retract as intended, and did not show evidence of the alleged issue or any defect that could have contributed to the event reported, the reported issues will be classified as "no problem detected".

• Brand Name: ACQUIRE
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• 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: 18094747
• Report Number: 3005099803-2023-06113
• Device Sequence Number: 6753986
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: 08714729931829
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/23/2025

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: 03/11/2025
• Device Model Number: M00555580
• Device Catalogue Number: 50277
• Device Lot Number: 0029032103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2023
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2022
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 52 KG