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

Catalog Number	MC1810
Medical Device Problem Codes	Failure to Obtain Sample (2533); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
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 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 ultrasound guided biopsy procedure through normal density tissue using maxcore instrument.During the procedure the device was unable to obtain the core in sample notch and its very hard to release both the stylet and cannula of the device.The procedure was completed by another device.There was no patient reported injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided biopsy through normal density tissue using maxcore instrument.During the procedure, the device was unable to obtain the core in sample notch and its very hard to release both the stylet and cannula of the device.The procedure was completed by another device.There was no patient reported injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one maxcore device was received for evaluation.Upon visual evaluation, the device was received with a needle protector and without a yellow guard attached to the needle.The device appeared to be clean and was received half primed with the top slide pulled back.No visual anomalies were noted to the device.During functional testing, the device was able to be fully primed with no issues.The device was further tested by cocking and firing the device three times in a chicken breast with each trigger, for a total of six tests.The device was able to prime and fire properly.All six samples were obtained with no issues.Therefore, the investigation is unconfirmed for the reported failure to fire and failure to obtain sample as the device was able to prime and fire properly.All six samples were obtained with no issues.A definitive root cause for the reported failure to fire and failure to obtain sample could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labelling or use related issue, a labelling review is not required.G3, h6 (method, result, conclusion) section a through f - the information provided by bd represents all of 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: 23277186
• Report Number: 2020394-2025-01659
• Device Sequence Number: 5506966
• Product Code: KNW
• UDI-Device Identifier: 00801741084461
• UDI-Public: (01)00801741084461(17)271231(10)REKN1585
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/27/2025

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: MC1810
• Device Lot Number: REKN1585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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