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); Failure to Reset (1532)
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 provided, a manufacturing review will 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 model f14105us biopsy instrument allegedly experienced during a breast biopsy in dense tissue, the device allegedly failed to reset and was allegedly difficult to remove from the patient after the second sample pass.It was further reported that the procedure was completed with another driver and probe.This report was received from one source.Patient was a (b)(6) year old female, weight not provided.This event involved one patient with no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation.The investigation is inconclusive for the alleged removal difficulty and failure to cycle.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the events indicated that model f14105us biopsy instrument allegedly allegedly failed to cycle and was allegedly difficult to remove.This report was received from one source.The patient was a 38 year old female, weight not provided.This event involved one patient with 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: 8807664
• Report Number: 2020394-2019-01609
• Device Sequence Number: 19676395
• 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,Followup
• Report Date (Section B): 01/17/2020

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
• Device Lot Number: 91007930
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1