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

Model Number	M00555540
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the pancreas during an endoscopic ultrasound-guided fine needle biopsy performed on (b)(6) 2024.During the procedure, the part of the device that controls the needle did not work.The needle did not move after insertion.The scope was removed with the needle.As a result, the procedure has been canceled due to another of the same device not being available.No further information obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of absence of treatment.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of absence of treatment.Block h11: investigation results the returned acquire needle was analyzed and showed no visible damage.The handle had evidence that the knobs were tightened, and a functional test confirmed that they were able to lock and unlock.The handle felt loose, and the needle would not extend.A destructive test was performed and found that the needle was broken and kinked inside the handle.The reported event was not confirmed.The needle extension failure and broken/kinked needle in the handle section could be due to the physician technique and excessive force.The needle would not advance smoothly during procedure and adding more pressure to the whole system could have damaged the needle inside the handle.Based on all available information, adverse event related to procedure was selected as the most probable root cause.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the pancreas during an endoscopic ultrasound-guided fine needle biopsy performed on (b)(6) 2024.During the procedure, the part of the device that controls the needle did not work.The needle did not move after insertion.The scope was removed with the needle.As a result, the procedure has been canceled due to another of the same device not being available.No further information obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18912548
• Report Number: 3005099803-2024-01055
• Device Sequence Number: 6769728
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 10/11/2024

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: 12/19/2025
• Device Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0030745389
• 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: 02/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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: 70 YR
• Patient Sex: Male