MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA 14G PROBE; BIOPSY INSTRUMENT

Model Number	F14105US
Medical Device Problem Codes	Failure to Cycle (1142); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction.A review of the events indicated that during a breast biopsy through very dense and fibrous tissue, model f14105us biopsy instrument was allegedly difficult to advance, failed to cycle, and then was difficult to remove from the patient.The procedure was completed using a different device.This report was received from one source.This event involved one (b)(6) female patient, weighing 144lbs.This patient had no reported patient injury.

• Brand Name: FINESSE ULTRA 14G PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8799151
• Report Number: 2020394-2019-01563
• Device Sequence Number: 2876974
• Product Code: KNW
• UDI-Device Identifier: 00801741085161
• UDI-Public: (01)00801741085161
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: No Information
• Device Model Number: F14105US
• Device Catalogue Number: F14105US
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1