MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MAXCORE; BIOPSY INSTRUMENT

Catalog Number	MC1416
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
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 not been returned to the manufacturer for evaluation.However, a video was provided for review.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) 2026, a patient underwent an ultrasound guided breast biopsy procedure through normal density tissue using maxcore instrument.During the procedure the device needle was bent, and needle was very difficult to remove from the patient body.No coaxial needle was used.The procedure was completed by another device.There was no patient reported injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided breast biopsy procedure through normal density tissue using maxcore instrument.During the procedure the device needle was bent, and needle was very difficult to remove from the patient body.No coaxial needle was used.The procedure was completed by another device.There was no patient reported injury.
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 electronic video was provided and reviewed.In that video, an hcp shows two maxcore device in initial position and he/she explains in native language, then one the device was noted to be bent on the tip of the needle.Second needle was shown for reference purpose.Based on the photo review the reported material twisted /bent event can be confirmed.Therefore, the investigation is confirmed for the reported needle bent as the tip of the needle noted to be bent.Therefore, the investigation is inconclusive for the reported difficult to remove as no objective evidence was provided for review.A definitive root cause for the alleged needle bent and difficult to remove could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• 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: 25092025
• Report Number: 2020394-2026-01111
• Device Sequence Number: 4836852
• Product Code: KNW
• UDI-Device Identifier: 00801741084430
• UDI-Public: (01)00801741084430(11)260106(17)280731(10)REKV0184
• 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): 05/12/2026

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: MC1416
• Device Lot Number: REKV0184
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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