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

Model Number	2016MSK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came in for an outpatient ct guided lung biopsy.Dr.[redacted] used bard biopsy needle as he normally does.He was able to get some samples at first but on his next attempt he said the needle was not going in.We stopped getting samples, dr [redacted] pulled the needle out, anyway we had enough samples according to the pathologist.Post procedure scan was done, and it showed small pneumothorax and a needle segment was noted on where the biopsy site was.Incident explained to patient and wife.

• 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: 25081076
• Report Number: 25081076
• Device Sequence Number: 10738384
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/14/2026
• Report Date (Section F): 04/14/2026

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
• Device Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: 0001632328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/14/2026