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

Catalog Number	MQ1410
Medical Device Problem Codes	Break (1069); Crack (1135); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
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 was performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 through normal tissue, the needle of the product allegedly didn't penetrate the tissue properly.It was further reported that notch length selection parts of product had fallen off.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy through normal tissue, the needle of the product allegedly didn't penetrate the tissue properly.It was further reported that notch length selection parts of product had fallen off.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: two marquee disposable core biopsy instruments were received for evaluation.During visual evaluation, both devices appeared to have residue throughout and also both device's penetration depth marker appeared to be detached from the device and was not returned.Also, a crack was noted to both device's depth adjustment plate.Upon functional testing, both needles were not noted to be dull at the distal end.Therefore, the investigation is inconclusive for the reported difficult to insert as the reported event can't able be replicated in the laboratory.The investigation is confirmed for the reported break as the penetration depth was noted to be broken from both received devices and also the investigation is confirmed for the identified crack as a crack was noted to both device's depth adjustment plate.A definitive root cause for the alleged difficult to insert, break and identified crack 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.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 through normal tissue, the needle of the product allegedly didn't penetrate the tissue properly.It was further reported that notch length selection parts of product had fallen off.There was no reported patient injury.
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 was evaluated.During visual evaluation, the device appeared to have residue throughout and also device's penetration depth marker appeared to be detached from the device and was not returned.Also, a crack was noted to the device's depth adjustment plate.Upon functional testing, the returned device's needle was not noted to be dull at the distal end.Therefore, the investigation is inconclusive for the reported difficult to insert as the reported event can't able be replicated in the laboratory.The investigation is confirmed for the reported break as the penetration depth was noted to be broken from the received device and also the investigation is confirmed for the identified crack as a crack was noted to the returned device's depth adjustment plate.A definitive root cause for the alleged difficult to insert, break and identified crack 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.D4 (unique identifier (udi) #), g3, h4, h6 (component, method) 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: 21261442
• Report Number: 2020394-2025-00029
• Device Sequence Number: 11846202
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133(11)240614(17)270428(10)0001567247
• 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,Followup
• Report Date (Section B): 07/07/2025

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 Catalogue Number: MQ1410
• Device Lot Number: 0001567247
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 07/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/17/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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