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

Model Number	M00555510
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	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.During the procedure, the needle was removed from the patient to expel samples and the entire needle fell out of the sheath.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block g2: medwatch # 4600100000-2022-8031.Block h2: block b5 and block g2 was updated with additional information received on november 21, 2022.Block h6: device code a0501 captures the reportable event of the tip of the entire needle fell out of the sheath.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2022.During the procedure, the needle was removed from the patient to expel samples and the entire needle fell out of the sheath.The procedure was completed with another expect slimline needle.There were no patient complications reported as a result of this event.Additional information received on november 21, 2022: the patient had an endoscopic ultrasound (eus) performed in the endoscopy or suite.While doctor was obtaining a needle aspiration specimen during the procedure, the needle from boston scientific expect slimline device became dislodge from the deployment device.The needle was retrieved and all parts of the device were accounted for.

• 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: 15829606
• Report Number: 3005099803-2022-06695
• Device Sequence Number: 20146343
• Product Code: ODG
• UDI-Device Identifier: 08714729848721
• UDI-Public: 08714729848158
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 09/13/2025
• Device Model Number: M00555510
• Device Catalogue Number: 5551
• Device Lot Number: 0030144999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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