MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC SIDEKICK RIGID NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number M0068903040

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Device was not functioning (x2) during case.During a procedure the device/needle needed to complete procedure was malfunctioning.Boston scientific sidekick rigid needle - two devices were opened both same lot #a00068450 - ref # (b)(4), gtin #(b)(4), exp - 6/17/2025.A new needle was opened & procedure was completed.

• Brand Name: BOSTON SCIENTIFIC SIDEKICK RIGID NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15799856
• MDR Text Key: 303824723
• Report Number: MW5113262
• Device Sequence Number: 2
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M0068903040
• Device Catalogue Number: 08714729819530
• Device Lot Number: A00068450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White