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

Catalog Number	MC1816
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2026, a patient underwent an ultrasound guided kidney biopsy procedure through tissue of normal density using a maxcore instrument.During the procedure, the device cannula failed to fire, and the firing button became stuck, although it could still be pressed.No coaxial needle was used.The procedure was completed using another device.There was no reported patient injury.This is report 6 of 7.
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided kidney biopsy procedure through tissue of normal density using a maxcore instrument.During the procedure, the device outer cannula failed to fire, and the firing bottom button became stuck, although it could still be pressed.No coaxial needle was used.The procedure was completed using another device.There was no reported patient injury.This is report 6 of 7.
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 not 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.One photo was provided and reviewed.In the photo, seven maxcore devices were visible with the packaging and labelling details noted to be sitting on a flat surface.Verified the same with trackwise.All the maxcore devices were in initial position with needle protective tubing and with yellow guard attached to the devices.No other anomalies were noted.Based on the review, reported event cannot be confirmed.Therefore, the investigation is inconclusive for the reported failure to fire as no objective evidence was shown in the provided photo to support the reported event for all the devices.A definitive root cause for the alleged 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.B5, g3, h6 (component, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50342519
• Report Number: 2020394-2026-02158
• Device Sequence Number: 5839600
• Product Code: KNW
• UDI-Device Identifier: 00801741084478
• UDI-Public: (01)00801741084478(11)260110(17)281031(10)REKY1711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/29/2026

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: MC1816
• Device Lot Number: REKY1711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2026
• 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