MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; BIOPSY NEEDLE

Model Number	M00555580
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Perforation (2001); Peritonitis (2252); Cholangitis (4821)
Date of Event	10/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of october 1, 2011, was chosen as the best estimate based on the start of the retrospective study date of october 2011.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block g2: literature source: nozomi okuno; makoto haba; kazuo hara."pd04-2 troubleshooting in eus-cds." 109th annual meeting of the japanese society for gastrointestinal endoscopy on-demand viewing (panel discussion 4).Block h6: imdrf patient code e1024 captures the reportable event of peritonitis.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e0506 captures the reportable event of bleeding.
Event or Problem Description
Boston scientific became aware of events involving acquire eus fnb needle 19g through the article: "pd04-2 troubleshooting in eus-cds," by nozomi okuno, et al.Per the article, a retrospective study included 200 cases out of 237 consecutive attempts, where endoscopic ultrasound-guided choledochoduodenostomy (eus-cds) procedures were performed as the primary drainage method between october 2011 to october 2024.Among 174 patients deemed eligible for eus-cds, early complications were observed in 6.9% (12/174), including peritonitis, acute cholangitis, double mucosal puncture, acute cholecystitis, fever, and bleeding.Please see the referenced article for full details and full listing of physicians and healthcare facilities.

• Brand Name: ACQUIRE
• Common Device Name: BIOPSY NEEDLE
• 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: 22470562
• Report Number: 3005099803-2025-03194
• Device Sequence Number: 19860269
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: (01)08714729931829
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: M00555580
• Device Catalogue Number: M00555580
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/10/2025
• 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: Required Intervention
• Patient Sex: Unknown