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

Model Number	M00550000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect 19g eus needle was used in the stomach fundus during a puncture under endoscopic ultrasonography procedure on (b)(6) 2025.During the procedure, the needle tip core was fractured during the biopsy puncture and was unable to puncture.Another expect needle was used to complete the procedure.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code reportablecode captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an expect 19g eus needle was used in the stomach fundus during a puncture under endoscopic ultrasonography procedure on (b)(6) 2025.During the procedure, the needle tip core was fractured during the biopsy puncture and was unable to puncture.Another expect needle was used to complete the procedure.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: correction to block b1 as this was inadvertently left blank on the previous submission.Block h6: imdrf impact code reportable code captures the reportable event of detachment of device or device component.Block h11: investigation results the returned expect needle was received for analysis.During the visual inspection, it was seen that the device returned with the working length kinked and needle broken right next to the luer.The reported event was confirmed because during the visual inspection, it was seen that the device returned with the working length kinked and needle broken right next to the luer.Based on the available information, the investigation findings were most likely that the technique used was the reason why the working length was found kinked, when the handle is not grabbed or secured carefully, the weight of the device itself can bend the working length.It can also occur if excessive force is being used to grab any of the components of the device.It's most likely that once the working length got kinked, the needle was broken due to force in which the device was being used.Therefore, a review and analysis of all available information indicates the most probable cause is adverse event related to procedure.

• Brand Name: EXPECT
• 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: 21681687
• Report Number: 3005099803-2025-01236
• Device Sequence Number: 12819667
• Product Code: ODG
• UDI-Device Identifier: 08714729790051
• UDI-Public: (01)08714729790051(17)270422(10)33873651
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110030
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: M00550000
• Device Catalogue Number: M00550000
• Device Lot Number: 0033873651
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG