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

Model Number	M00555640
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound-guided fine-needle aspiration (eus-fna) procedure on (b)(6) 2024.During the procedure, the needle tip length was adjusted at the time of puncture and the helix was tightened to puncture the needle, but the force of the puncture caused the stopper to shift and the needle was punctured deeper than the intended target site.The blood vessel was damaged and bleeding occurred.The patient is currently under observation.When the retrieved device was inspected, traces of the stopper having shifted was found.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.Block h11: investigation results the returned acquire needle was received for analysis.Visual examination revealed that the working length cut and the needle broken and kinked and the device needle lock knob was found crooked.In addition, the handle was found damaged.The reported event was not confirmed because happened during the procedure and there is not an objective evidence or descriptive conditions to confirm the reported events.Based on the available information, the investigation findings were most likely handling of the device during the procedure or the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Also, the device's needle lock knob was found crooked.This could have happened as result of tightening the knob with too much force during the procedure, making the knob exceed the tightening limit and getting crooked and once the knob is in this state it's most likely that it won't work as it did before it got damaged even if it's tried to place the knob on its original position.Additionally, there's evidence of a mechanical cut in the working length and needle.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used during an endoscopic ultrasound-guided fine-needle aspiration (eus-fna) procedure on (b)(6) 2024.During the procedure, the needle tip length was adjusted at the time of puncture and the helix was tightened to puncture the needle, but the force of the puncture caused the stopper to shift and the needle was punctured deeper than the intended target site.The blood vessel was damaged and bleeding occurred.The patient is currently under observation.When the retrieved device was inspected, traces of the stopper having shifted was found.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• Brand Name: ACQUIRE S
• 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: 21118422
• Report Number: 3005099803-2024-06852
• Device Sequence Number: 18027164
• Product Code: ODG
• UDI-Device Identifier: 00191506030742
• UDI-Public: 00191506030742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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 Model Number: M00555640
• Device Catalogue Number: M00555640
• Device Lot Number: 0034669855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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