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

Catalog Number	MQ1610
Medical Device Problem Codes	Break (1069); Failure to Fire (2610); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2025
Type of Reportable Event	Serious 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 device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a breast biopsy procedure, the tip of the stylet was allegedly had broken.Further, the broken tip was stuck inside the patient's breast.The patient is scheduled for breast cancer surgery in the near future, and at this time, patient does not want to have additional surgery for removing the remaining tip.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot meets all the release criteria.Investigation summary: one marquee disposable core biopsy instrument was received for evaluation.Two electronic photos were provided and reviewed, both capturing the fractured edge of the marquee stylet needle from different angles.No additional visual anomalies were observed in the images.The device arrived with protective tubing and appeared to have residue on the outer housing.The penetration depth marker was set to 25mm, and the device was received in its initial position.Upon disassembly, a break was observed at the distal end of the stylet, and blood-like residue was noted throughout the stylet.When placed against a straight-edge ruler, the stylet exhibited a slight bend.Signs of use were evident on both the automatic and semi-automatic triggers, as indicated by wear on the stylet and cannula hubs.Additionally, damage was observed on the cutting cannula.Dimensional measurements of the sample notch thickness were performed and found to be within the acceptable specification range.Based on the evaluation findings, the investigation confirms the reported break, as a fracture was observed at the distal end of the stylet.The investigation also confirms the identified bend, as a curvature was noted on the stylet, and confirms material deformation due to damage observed on the cutting cannula.However, the investigation remains inconclusive for the reported failure to fire, as functional testing could not be performed due to the condition of the returned device.A definitive root cause for the reported break, failure to fire, identified bend, and material deformation could not be determined based on the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g2, g3, h4, h6 (device, component, 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 an ultrasound guided breast biopsy procedure through normal density tissue using marquee device.During the procedure, it was reported that the tip of the stylet was allegedly broken.Further, the broken tip was stuck inside the patient's breast.It was further reported that physician pressed button a, but only stylet was fired and cutting canula has allegedly failed to fire.The patient is scheduled for breast cancer surgery in the near future.At this time, the patient does not want to have additional surgery for removing the remaining tip.No coaxial was used.

• 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: 22409402
• Report Number: 2020394-2025-00979
• Device Sequence Number: 9795622
• Product Code: KNW
• UDI-Device Identifier: 00801741097164
• UDI-Public: (01)00801741097164(11)250115(17)271128(10)0001601375
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MQ1610
• Device Lot Number: 0001601375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown