MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT SLIMLINE (SL); ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	50262
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2306 captures the reportable event of resuscitation.Imdrf impact code f0801 captures the reportable event of intensive care.Imdrf impact code f21 captures the reportable event of unexpected deterioration.Imdrf patient code e0506 captures the reportable event of hemorrhage.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during a procedure to insert a coil to control a bleeding gastric varix on (b)(6) 2025.During procedure, the expect slimline needle was inserted in the varix, the area was very mobile due to respirations and hiccupping.The stylet was removed from the needle; a coil was placed in the needle and the stylet was attempted to be advanced to push the coil into the varix and stop the bleeding.The coil would only advance to about the halfway point and became stuck the scope was attempted to be repositioned but was unsuccessful.A gastroscope was put up to glue the varix under endoscopic view, but the varix started bleeding and the patient became unstable.A code 66 was called and resuscitation was initiated; the patient was intubated after the scope was removed.The patient was admitted to icu where the varix was injected with glue to stop the bleeding.Another expect slimline needle was opened outside the patient and a coil was attempted be advanced through the needle and it also became stuck.According to the indication for use set by the manufacturer, the device is intended to be used for the delivery of injectable materials (fluids) or fiducials.However, in this case the physician attempted to use coils.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during a procedure to insert a coil to control a bleeding gastric varix on (b)(6) 2025.During procedure, the expect slimline needle was inserted in the varix, the area was very mobile due to respirations and hiccupping.The stylet was removed from the needle, a coil was placed in the needle and the stylet was attempted to be advanced to push the coil into the varix and stop the bleeding.The coil would only advance to about the half way point and became stuck the scope was attempted to be repositioned but was unsuccessful.A gastroscope was put up to glue the varix under endoscopic view, but the varix started bleeding and the patient became unstable.A code 66 was called and resuscitation was initiated, the patient was intubated after the scope was removed.The patient was admitted to icu where the varix was injected with glue to stop the bleeding.Another expect slimline needle was opened outside the patient and a coil was attempted be advanced through the needle and it also became stuck.According to the indication for use set by the manufacturer, the device is intended to be used for the delivery of injectable materials (fluids) or fiducials.However, in this case the physician attempted to use coils.Additional information was received on february 03, 2026.The needle was in place when the patient complications occurred.
Additional Manufacturer Narrative
Block h2: additional information block b5 was updated based on the additional information received on february 03, 2026.Block h6: imdrf impact code f2306 captures the reportable event of resuscitation.Imdrf impact code f0801 captures the reportable event of intensive care.Imdrf impact code f21 captures the reportable event of unexpected deterioration.Imdrf patient code e0506 captures the reportable event of hemorrhage.

• Brand Name: EXPECT SLIMLINE (SL)
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24246542
• Report Number: 3005099803-2026-00425
• Device Sequence Number: 9657444
• Product Code: ODG
• UDI-Device Identifier: 08714729848714
• UDI-Public: (01)08714729848714(17)280921(10)37817348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 50262
• Device Catalogue Number: 50262
• Device Lot Number: 0037817348
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 09/22/2025
• 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