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

Model Number	M00555500
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an endoscopic guided biliary drainage procedure performed on (b)(6) 2021.During the procedure, the needle could not advance through the endoscope.The needle was withdrawn and it was noted that the working length was bent.The endoscope channel was damaged and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a27 captures the reportable event of an aborted procedure.Block h10: investigation results: the returned expect slimline needle was analyzed, a visual evaluation was performed and observed that the stylet returned loaded into the device and the working length was kinked/bent at the proximal section and the distal end.In addition.A functional evaluation was performed by actuating the handle in which the needle extended and retracted without any issues.In addition, the stylet was removed and inserted with some resistance due to the kinks in the sheath.No other issues were noted.Based on all available information and the condition of the returned device, the kinks presented in the working length could be related to user manipulation and/or technique while setting up the device during the procedure.Moreover, an excess of force applied to the device or interaction with other another device could have affected the device performance during it use,.This could cause resistance when the user tried to insert the device in the scope.The investigation concluded the most probable cause of the analyzed failure is adverse event related to procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that an expect slimline needle was used during an endoscopic guided biliary drainage procedure performed on (b)(6) 2021.During the procedure, the needle could not advance through the endoscope.The needle was withdrawn and it was noted that the working length was bent.The endoscope channel was damaged and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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
• MDR Report Key: 12487983
• Report Number: 3005099803-2021-04681
• Device Sequence Number: 16981693
• Product Code: ODG
• UDI-Device Identifier: 08714729848141
• UDI-Public: 08714729848141
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 12/04/2023
• Device Model Number: M00555500
• Device Catalogue Number: 5550
• Device Lot Number: 0026464711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1