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

Model Number	M00555501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detached.Imdrf impact code f2301 captures the event that an additional device was used to remove the needle.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline (sl) was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the needle detached itself from the handle.The needle was successfully removed without damaging the scope or injury to the patient.The procedure was completed with another same device.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline (sl) was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the needle detached itself from the handle.The needle was successfully removed without damaging the scope or injury to the patient.The procedure was completed with another same device.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detached.Imdrf impact code f2301 captures the event that an additional device was used to remove the needle.Block h11: the returned expect slimline (sl) was analyzed, and product analysis observed that the working length is kinked.After disassembling the handle, the needle was found kinked and detached inside.The reported event that the needle detached was confirmed.Based on all available information, the technique used could be the reason the working length kinked.When the handle was not grab or secured carefully, the weight of the device itself can bend the working length.Additionally, it can also happen that excessive force was used in grabbing any components of the device affecting the needle.Also affecting the needle is the excessive force used when extending or retracting the needle as seen when disassembling the handle and exposing the needle.Therefore, the most probable 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: 20346608
• Report Number: 3005099803-2024-04823
• Device Sequence Number: 7931362
• Product Code: ODG
• UDI-Device Identifier: 08714729848714
• UDI-Public: 08714729848714
• 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): 12/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00555501
• Device Catalogue Number: 50262
• Device Lot Number: 0033637398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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