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

Catalog Number	MQ1610
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiry date: 02/2026) 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.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy procedure, the device allegedly had weak firing power and was unable to get sufficient samples.It was further reported that the needle had to be forcibly removed from the breast.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy procedure, the device allegedly had weak firing power and was unable to get sufficient samples.It was further reported that the needle had to be forcibly removed from the breast.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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: received one marquee disposable core biopsy instruments for evaluation.Upon visual evaluation, the device was appeared to have blood residue throughout the cannula and the penetration depth marker was set to 25mm.The device was received in its initial position.No visual anomalies were noted to the device.The device was able to be fully primed with no issues.The device was further tested by cocking and firing the device 12 times at the 18mm and 25mm into a pork shoulder using the automatic and semiautomatic firing options.The device was able to prime and fire properly.All 24 samples were obtained.Therefore, the investigation is unconfirmed for the reported failure to fire as the device was able to prime, fire and obtain samples without any issues and 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 failure to fire and difficult to remove issues 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.H10: d4 (expiry date: 02/2026).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.

• 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: 19496133
• Report Number: 2020394-2024-00787
• Device Sequence Number: 15606315
• Product Code: KNW
• UDI-Device Identifier: 00801741097164
• UDI-Public: (01)00801741097164
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 06/13/2024

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: MQ1610
• Device Lot Number: 0001511890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2023
• 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