MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MISSION; INSTRUMENT, BIOPSY

Model Number	2016MSK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was in ir (interventional radiology) for a computer-tomography (ct) guided biopsy.Medical doctor used ct imaging to locate the target, l5-s1 disc.A 20g 16 cm bard mission needle was chosen.The disc space was reached using ct fluoroscopy.During sample collection, md asked for a second bard mission needle.After a few specimens were collected md removed the needle and stylet.He stated that a piece of the needle broke off and left behind.It was visible on ct fluoroscopy imaging.

• Brand Name: MISSION
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 21605296
• Report Number: 21605296
• Device Sequence Number: 8868189
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096(17)271028(10)0001598002
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025
• Report Date (Section F): 02/26/2025

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 Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: 0001598002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 02/26/2025