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

Model Number	M00555540
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter city (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.
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 aspiration (eus-fna) procedure performed on (b)(6) 2024.During the procedure, the sheath did not come out even after adjusting the sheath stopper.After pushing for a while, the sheath came out as if it was popping out, and the same movement was observed when acquire was passed through the scope outside the body.The procedure was discontinued due to the possibility of a scope malfunction.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter city (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.Block h11: investigation results: the returned injection gold probe device was analyzed, and visual analysis found that the sheath adjustment knob was crooked.A functional evaluation was performed by attempting to adjust the sheath adjustment knob; however, the knob did not fully adjust since it was crooked.No other issues were noted.The reported event of knob failure to adjust was confirmed.The sheath adjustment knob damaged could have happened as a result of tightening the knob with too much force during the procedure or making the knob exceed the tightening limit.Based on all available information, the most probable root cause of the reported clinical observations is adverse event related to procedure.
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 aspiration (eus-fna) procedure performed on (b)(6) 2024.During the procedure, the sheath did not come out even after adjusting the sheath stopper.After pushing for a while, the sheath came out as if it was popping out, and the same movement was observed when acquire was passed through the scope outside the body.The procedure was discontinued due to the possibility of a scope malfunction.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: 19133424
• Report Number: 3005099803-2024-01702
• Device Sequence Number: 4631326
• Product Code: ODG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2024

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 Model Number: M00555540
• Device Catalogue Number: 5554
• Device Lot Number: 0032817031
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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