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

Catalog Number	MC1820
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a kidney biopsy procedure by using maxcore device.It was reported that during the procedure, the inner needle and ejector needle allegedly failed to eject synchronously, resulting in an ineffective section.No coaxial needle was used.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 is currently being 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 provided 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: two maxcore disposable core biopsy instrument received.On visual testing in sample 1, the device appeared to be clean.The device was received with a needle protector and without a yellow guard attached to the needle.Instrument was received with both slides in their initial positions.No anomalies were noted to the device.In sample 2, the device appeared to have residue throughout the needle.The device was received with a needle protector and with a yellow guard attached to the needle.Instrument was returned half primed with the top slide pulled back and the bottom slide in the initial position, leaving the sample notch exposed.Upon functional testing in sample 1, to prime the top and the bottom slide was then pushed into the device and was able to lock into the device.The device was fully primed with no issues.The device was further tested by cocking and firing the device 3 times into the chicken breast.The device was able to prime and fire properly.All 6 samples were collected with no issue.In sample 2, due to the condition of device, no functional testing was performed.Therefore, the investigation is unconfirmed for the reported failure to fire in sample 1 as the device was able to prime, fire properly and all 6 samples were collected with no issue.However, the investigation is inconclusive for the reported reported failure to fire in sample 2 as functional was not performed due to the condition of the return sample.A definitive root cause for the reported failure to fire 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, h6 (method, result, conclusion).Section a through f ¿ the information provided 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) 2026, a patient underwent a kidney biopsy procedure by using maxcore device.It was reported that during the procedure, the inner needle and ejector needle allegedly failed to eject synchronously, resulting in an ineffective section.No coaxial needle was used.The procedure was completed using another device.There was no reported patient injury.

• 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: 24515926
• Report Number: 2020394-2026-00576
• Device Sequence Number: 8504705
• Product Code: KNW
• UDI-Device Identifier: 00801741084485
• UDI-Public: (01)00801741084485(11)251008(17)280831(10)REKW1372
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: MC1820
• Device Lot Number: REKW1372
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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