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

Catalog Number F14105US

Device Problems Difficult to Remove (1528); Failure to Reset (1532); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number was not provided; a review of the device history records has not been performed.The return of the device is pending.The investigation 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 Description

It was reported that during a breast biopsy in a hard density lesion, at the second 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 and attempts to reset the device allegedly failed.Reportedly, the procedure was completed with another device.There was no reported patient injury.

Event Description

It was reported that during a breast biopsy in a hard density lesion, at the second 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 and attempts to reset the device allegedly failed.Reportedly, the procedure was completed with another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the finesse 14g biopsy probe was not returned for evaluation.Therefore, the investigation is inconclusive for failure to reset and difficult to remove as the sample was not available for functional evaluation and no objective evidence was provided for review.Per the reported event, the device jammed and could not be reset.It is possible that the tissue was not completely excised which caused the probe to be difficult to remove.It is possible that patient factors and/or procedural issues contributed to the reported event; however, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: FINESSE ULTRA BREAST BIOPSY SYSTEM
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7934717
• MDR Text Key: 122821567
• Report Number: 2020394-2018-01850
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741085161
• UDI-Public: (01)00801741085161
• Combination Product (y/n): N
• PMA/PMN Number: K093068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F14105US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 66