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

Model Number	M00555531
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used in the lungs during an endoscopic ultrasound (eus) procedure performed on (b)(6)2022.During the procedure, one lymph node was punctured successfully with the expect needle three times.However, after puncturing the second lymph node on the second attempt time the resistance in the handle was gone and the needle in the patient wasn't extending or retracting.The needle was still 2 cm out, but they carefully removed the needle together with the scope.The procedure was aborted.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used in the lungs during an endoscopic ultrasound (eus) procedure performed on (b)(6)2022.During the procedure, one lymph node was punctured successfully with the expect needle three times.However, after puncturing the second lymph node on the second attempt time the resistance in the handle was gone and the needle in the patient wasn't extending or retracting.The needle was still 2 cm out, but they carefully removed the needle together with the scope.The procedure was aborted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results: the returned acquire eus fnb needle was analyzed, and a functional evaluation noted that the needle could not be retracted correctly.The handle was disassemble and it was revealed that the needle was detached from the proximal luer.No other issues were noted.Based on all available information and the condition of the returned device, the device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.The investigation concluded the most probable cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 14003928
• Report Number: 3005099803-2022-01519
• Device Sequence Number: 20116599
• Product Code: ODG
• UDI-Device Identifier: 08714729848806
• UDI-Public: 08714729848806
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/20/2022

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: 01/19/2025
• Device Model Number: M00555531
• Device Catalogue Number: 50266
• Device Lot Number: 0028714767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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