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

Catalog Number	MC1825
Medical Device Problem Codes	Break (1069); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent an echo guided prostate biopsy through normal density tissue using the maxcore device.During the procedure, the device allegedly made an abnormal sound or minimal to no sample was obtained.The procedure was completed by 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.Investigational summary: received maxcore disposable core biopsy instrument for evaluation.The device was received without a needle protector and without a yellow guard attached to the needle.Upon visualization the device appeared to be clean and was received with both slides in their initial positions.It was observed that there was a break to the needle leaving a small piece of the sample notch exposed.A break complete circumferential break was noted to the cannula.Due to the condition of the returned device, no functional testing was performed.Therefore, the investigation is confirmed for the identified cannula break, and the investigation is kept as inconclusive for the reported failure to obtain sample as the further functional testing was not performed due to the condition of the returned device.A definitive root cause for the alleged failure to obtain sample and identified cannula break 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.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: 25387028
• Report Number: 2020394-2026-01444
• Device Sequence Number: 16120158
• Product Code: KNW
• UDI-Device Identifier: 00801741084492
• UDI-Public: (01)00801741084492(11)250809(17)280630(10)REKU1242
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: MC1825
• Device Lot Number: REKU1242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2025
• 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: Male