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

Model Number	5564
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e0505 captures the reportable event of the hematoma.Imdrf impact code f08 captures the reportable event of hospitalization beyond the standard of care.Imdrf impact code f23 captures the reportable event of hematoma evacuation to treat the hematoma.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the duodenum during an endoscopic ultrasound biopsy procedure performed on (b)(6) 2024.Post procedure on (b)(6) 2024, the patient developed a hematoma and was hospitalized beyond the standard of care.A hematoma evacuation was performed to resolve the hematoma.The patient was reported to be doing fine and is out of the hospital.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h2: correction block g1 has been corrected to the correct manufacturer information.Block h6: imdrf patient code e0505 captures the reportable event of the hematoma.Imdrf impact code f08 captures the reportable event of hospitalization beyond the standard of care.Imdrf impact code f23 captures the reportable event of hematoma evacuation to treat the hematoma.
Event or Problem Description
It was reported to boston scientific corporation that an acquire needle was used in the duodenum during an endoscopic ultrasound biopsy procedure performed on (b)(6) 2024.Post procedure on (b)(6) 2024, the patient developed a hematoma and was hospitalized beyond the standard of care.A hematoma evacuation was performed to resolve the hematoma.The patient was reported to be doing fine and is out of the hospital.

• 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; IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 20413714
• Report Number: 3005099803-2024-04883
• Device Sequence Number: 20885229
• Product Code: ODG
• UDI-Device Identifier: 00191506030742
• UDI-Public: 00191506030742
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5564
• Device Catalogue Number: 5564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown