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

Catalog Number MC1410

Device Problems Self-Activation or Keying (1557); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one maxcore disposable core biopsy instrument was returned for evaluation.On visual evaluation, the device appeared to have residue throughout and device was returned half primed, leaving the sample notch exposed.On functional evaluation, the device self-activated.A drop test was performed and the device failed in the drop test as the top slide self-activated.Upon disassembly, it was noted that the left bumper was found to be bent.Additionally, the tangs did not appear to be damaged or deformed.Therefore, the investigation for the identified self-activation is confirmed as the device self-activated during functional testing.However, the investigation remains inconclusive for the reported failure to fire as the further functional testing was not performed.A definitive root cause for the alleged reported failure to fire and identified self-activation 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.H10: d4 (expiration date: 11/2024) h11: 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 Description

It was reported that during an ultrasound guided breast biopsy procedure through normal density tissue, the cutting cannula of the device allegedly failed to deploy.No coaxial was used and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: MAXCORE
• Type of Device: 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: 18586691
• MDR Text Key: 333927935
• Report Number: 2020394-2024-00122
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084423
• UDI-Public: (01)00801741084423
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1410
• Device Lot Number: REFZ0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1