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

Catalog Number	MQK1825
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a prostate biopsy procedure using the marquee kit.During the procedure, the needle became stuck in the rectal probe guide.There was significant difficulty in removal, and the tip of the gun appeared to be broken.It was further reported that the patient experienced discomfort, and considerable traction was required to extract the equipment.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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 disposable core biopsy instrument received for evaluation.The device appeared to have residue on the distal tip of the stylet.The device received without protective tubing and received in its initial position.The penetration depth marker was set to 25mm.Material deformation was observed to the distal tip of the stylet.During microscopic evaluation the distal tip of the stylet was noted to be dull/blunt.Functional testing was not performed due to the condition of the returned device.Therefore, the investigation is confirmed for the identified dull as the distal tip of the stylet was noted to be dull/blunt and the investigation is unconfirmed for the reported break as no breaks were noted to the device.The investigation is kept as inconclusive for the reported difficult to remove issue as the condition of use cannot be replicated in the laboratory.A definitive root cause for the reported break, difficult to remove and identified dull/blunt issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, d4 (unique identifier (udi) #), h6 (device, method, result, conclusion).Section a through f: the information provided 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
On (b)(6) 2025, a patient underwent a prostate biopsy procedure using the marquee kit.During the procedure, the needle became stuck in the rectal probe guide.There was significant difficulty in removal, and the tip of the gun appeared to be broken.It was further reported that the patient experienced discomfort, and considerable traction was required to extract the equipment.The procedure was completed using another device.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: 23355906
• Report Number: 2020394-2025-01736
• Device Sequence Number: 8888287
• Product Code: KNW
• UDI-Device Identifier: 00801741097379
• UDI-Public: (01)00801741097379(11)250720(17)280528(10)0001627839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Catalogue Number: MQK1825
• Device Lot Number: 0001627839
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2025
• 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: Male