MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Marquee; Biopsy Instrument

Catalog Number	MQ1825
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, a male patient underwent an ultrasound guided prostate biopsy procedure using a marquee biopsy instrument via a transrectal approach.During the procedure, the biopsy cannula bent after four tissue samples were obtained.A second instrument with the same reference number and lot number was subsequently used; however, the same issue recurred, with the biopsy cannula bending after four tissue samples were collected.It was further reported that difficulty was encountered while withdrawing the bent cannula from the patient.The procedure was ultimately completed using a third device.The patient experienced discomfort and pain, for which 1percent lidocaine was administered.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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H.4.Device manufacture date: unknown.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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50893713
• Report Number: 2020394-2026-02812
• Device Sequence Number: 17618243
• Product Code: KNW
• UDI-Device Identifier: 00801741097225
• UDI-Public: (01)00801741097225(17)290128(10)0001662706
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2026

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: MQ1825
• Device Lot Number: 0001662706
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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