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

Model Number F14105US

Device Problems Failure to Cycle (1142); Difficult to Remove (1528); Failure to Reset (1532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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 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
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8807664
• MDR Text Key: 151601084
• Report Number: 2020394-2019-01609
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741085161
• UDI-Public: (01)00801741085161
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: F14105US
• Device Catalogue Number: F14105US
• Device Lot Number: 91007930
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1