MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT

Catalog Number	F14105US
Medical Device Problem Codes	Failure to Cycle (1142); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during a breast biopsy, at the fourth sample pass, the needle of the device allegedly jammed and unable to be removed from driver.It was further reported, the needle was difficult to remove from the tissue.Reportedly, the procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one finesse 14g biopsy probe and driver were returned.Upon visual inspection, a bent needle was noted extending out of the probe housing preventing full functional testing.The bend was not originally reported and it is unknown if shipping/handing factors contributed to the returned condition.Therefore, the bend was considered an incidental finding.Although the service hatch was accessed to remove the probe from the driver, a specific failure mode could not be determined.The driver was tested with an in-house probe and no issues were noted during initialization, sample acquisition, sample storage, and system reset.The investigation is, therefore, inconclusive for failure to cycle and difficult to remove from the tissue.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that during a breast biopsy, at the fourth sample pass, the needle of the device allegedly jammed and was unable to be removed from driver.It was further reported, the needle was difficult to remove from the tissue.Reportedly, the procedure was completed with another device.There was no reported patient injury.

• Brand Name: FINESSE ULTRA BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7386107
• Report Number: 2020394-2018-00308
• Device Sequence Number: 16401476
• Product Code: KNW
• UDI-Device Identifier: 00801741085161
• UDI-Public: (01)00801741085161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Expiration Date: 06/14/2020
• Device Catalogue Number: F14105US
• Device Lot Number: 91007845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 68