MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT SLIMLINE SL; BIOPSY NEEDLE

Model Number	M00555510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Septic Shock (2068); Peritonitis (2252)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: estimated based on the date of the 109th annual meeting of the japan gastroenterological endoscopy society on-demand viewing.Block g2: study ws07-12 eus-hgs in the elderly by keigo oshiro, nozomi okuno, and kazuo hara from the aichi cancer center.Block h6: patient code e233605 captures the reportable event of septic shock.Patient code e1024 captures the reportable event of peritonitis.Patient code e2326 captures the reportable event of cholecystitis.
Event or Problem Description
Boston scientific became aware of an event involving an expect slimline sl from the 109th annual meeting of the japan gastroenterological endoscopy society on-demand viewing (workshop 7) titled eus-hgs in the elderly, by keigo oshiro, et al.Per the study, the safety and clinical outcomes of eus-hgs in elderly patients were examined retrospectively from january 2017 to september 2024.Severe complications mentioned includes septic shock, peritonitis, and cholecystitis.Please see the referenced article for full details.

• Brand Name: EXPECT SLIMLINE SL
• 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: 22470773
• Report Number: 3005099803-2025-03150
• Device Sequence Number: 17168041
• Product Code: ODG
• UDI-Device Identifier: 08714729848158
• UDI-Public: (01)08714729848158
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional
• 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: M00555510
• Device Catalogue Number: M00555510
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown