MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MARQUEE; BIOPSY INSTRUMENT

Catalog Number	MQ1410
Medical Device Problem Codes	Crack (1135); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure, the gun was allegedly not removed from patient after shooting.It was further reported that the needle was completely bent from the guide needle.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f: the information provide by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one marquee device with one loaded truguide coaxial cannula (captured under pr# (b)(4)) was received for evaluation.Upon visual evaluation, the device appeared to have blood residue throughout the cannula and received without protective tubing.Material deformation was noted to the distal end of the truguide and the distal end of the sample notch.The distal end of the sample notch was noted to be split.Due to the nature of the device, no functional testing was performed.The penetration depth button was removed to observe the penetration depth plate.A crack was noted to the penetration depth plate.Dimensional observation was performed for sample notch thickness and the values are within acceptable range.Therefore, the investigation is inconclusive for the reported device-device incompatibility as no objective evidence was provided for review.However, the investigation is confirmed for the reported difficult to remove as the instrument was unable to be removed from the coaxial.The investigation is also confirmed for the identified material deformation as material deformation was noted to the distal end of the sample notch.And the investigation is also confirmed for the identified crack as a crack was noted on the depth adjustment plate.It may be likely that the use of the marquee instrument with the truguide coaxial cannula, contributed to the reported event.However, a definitive root cause for the reported device-device incompatibility, reported difficult to remove, identified material deformation and identified crack issue could not be determined based upon the provided information.Labeling review: per the bard marquee disposable core biopsy instrument instructions for use (ifu - baw1568700 rev.1) the bard marquee disposable core biopsy instrument is available as a biopsy instrument only and as a kit, which includes the bard marquee disposable core biopsy instrument and compatible coaxial biopsy needle.Per the bard truguide disposable coaxial biopsy needle instructions for use (ifu - baw1280500, rev.4) how supplied section, c1410b is compatible with bard biopsy needle (magnum and biopty-cut).G3, h6 (device, component, method, result).Section a through f: the information provide by bd represents all 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
It was reported that during a breast biopsy procedure, the gun was allegedly not removed from patient after shooting.It was further reported that the needle was completely bent from the guide needle.There was no reported patient injury.

• Brand Name: MARQUEE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21126880
• Report Number: 2020394-2024-01993
• Device Sequence Number: 12658186
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133(11)231015(17)260828(10)0001534279
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 08/28/2026
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001534279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown