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

Model Number	M00555530
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used in the liver during a liver biopsy procedure performed on (b)(6) 2024.During the procedure, the inner sheath was detached and remained inside of the endoscope.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sheath detached.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used in the liver during a liver biopsy procedure performed on (b)(6) 2024.During the procedure, the inner sheath was detached and remained inside of the endoscope.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sheath detached.Block h10: investigation results: the expect slimline needle was returned, and a visual inspection observed that the needle is broken, the needle knob is crooked, and the working length is kinked on various sides.No other problems noted.The reported event of sheath detached was not confirmed.Based on the available information, it is most likely that the technique used was the reason why the working length was found kinked.When the handle is not secured carefully, the weight of the device itself can bend the working length.This can also happen if excessive force is being used to grab any of the components of the device.It's most likely that the needle broke due to the severity of the kink found on the working length.In addition, the needle locking knob damage could have happened as result of tightening the knob with too much force during the procedure, making the knob exceed the tightening limit.Based on all available information and analysis of the returned device, the most probable root cause is adverse event related to procedure.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18894647
• Report Number: 3005099803-2024-01012
• Device Sequence Number: 6410296
• Product Code: ODG
• UDI-Device Identifier: 08714729848172
• UDI-Public: 08714729848172
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2026
• Device Model Number: M00555530
• Device Catalogue Number: 5553
• Device Lot Number: 0032194761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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
• Patient Sex: Unknown