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

Catalog Number	MC1610
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guide kidney biopsy procedure via normal density tissue by using the maxcore.It was reported that during the procedure, the device allegedly failed to fire.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 was performed.The device has been returned to the manufacturer for evaluation.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 an ultrasound guide kidney biopsy procedure via normal density tissue by using the maxcore.It was reported that during the procedure, the device allegedly failed to fire.The procedure was completed using another device.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 maxcore disposable core biopsy instrument was received for evaluation.Upon visual evaluation, the device appeared to have residue on the distal tip of the stylet.The device was returned fully primed, with the top and bottom slide pulled back.Due to the condition of the device, no functional testing was performed.Therefore, the investigation is inconclusive for the reported failure to fire as no functional testing was performed due to the condition of the device.A definitive root cause for the reported failure to fire 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.G3, h6 (method, result, conclusion).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: MAXCORE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24387070
• Report Number: 2020394-2026-00326
• Device Sequence Number: 21402355
• Product Code: KNW
• UDI-Device Identifier: 00801741084447
• UDI-Public: (01)00801741084447(11)250531(17)280331(10)REKR2278
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: MC1610
• Device Lot Number: REKR2278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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: Unknown