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

Catalog Number	MC1410
Medical Device Problem Codes	Failure to Fire (2610); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using maxcore instrument.During the procedure the needle was inserted into the breast and fired.However, the tissue acquisition mechanism at the tip of the needle (needle notch) did not function properly.There was patient reported injury with skin deformation and trauma in the breast area.Current patient status is unknown.
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 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 sample, one maxcore disposable core biopsy instrument was evaluated.The device appeared to clean and received in the initial position.The device received without needle protector and yellow guard.Upon visual evaluation, a backwards bend was noted to sample notch when placed against a straight edge ruler.Due to the bent sample notch, no functional testing was performed.Therefore, the investigation is confirmed for the identified bent issue as bent noted to sample notch.The investigation is inconclusive for failure to fire issue as no functional testing was not performed.A definitive root cause for the 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 (device, component, method, result).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) 2025, a patient underwent a biopsy procedure using the maxcore instrument.During the procedure, the needle was inserted into the breast and fired.However, the tissue acquisition mechanism at the tip of the needle (needle notch) did not function properly.The patient reported injury, including skin deformation and trauma in the breast area.The current status of the patient is unknown.

• 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: 23388374
• Report Number: 2020394-2025-01764
• Device Sequence Number: 9945233
• Product Code: KNW
• UDI-Device Identifier: 00801741084423
• UDI-Public: (01)00801741084423(11)240605(17)270430(10)REJS2322
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC1410
• Device Lot Number: REJS2322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female