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

Model Number	M00555640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of september 13, 2024.Block h6: imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that a acquire s eus fnb needle 22g box 1 was used in the duodenum during an endoscopic ultrasound biopsy procedure performed on (b)(6) 2024.During procedure, the acquire needle was treated for hematoma.Happen 3 separate times since conversion another endoscopic ultrasound biopsy was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of september 13, 2024.Block h6: imdrf impact code f08 captures the reportable event of hospitalization.Block h11: block b3 (date of event), block d4 (model number), block g1 (manufacturing site), and block g1 (mfr contact first and last name) has been corrected.
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 an unknown date.Post procedure, the patient developed a hematoma.The hematoma resolved on its own without treatment, however the patient was hospitalized overnight beyond the standard of care.

• 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: 20413169
• Report Number: 3005099803-2024-04882
• Device Sequence Number: 8257386
• 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): 11/07/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00555640
• 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: 10/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown