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

Catalog Number	MQ1410
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Prime (1492); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy procedure, the device allegedly failed to slide to open the trough to remove the sample.The procedure was completed using another device.There was no reported patient injury.
Additional 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 marquee disposable core biopsy instrument was received for evaluation.During visual evaluation, the device appeared to be clean, and the device was received in its initial position with the penetration depth marker set to 25mm and no visual anomalies were noted to the device.Upon functional testing, the device was able to fully prime with no issues.Upon firing the device however, the trocar stylet did not fully fire as the sample notch was not exposed.The device was disassembled for further evaluation and visual inspection.It was noted that the cannula was detached from the hub, the required sandblasting was non-homogenous, and the cannula end was not flared.Therefore, the investigation for the reported failure to prime issue remains inconclusive as it is unknown if the identified issues contributed to the reported event.The investigation is confirmed for the identified failure to fire issue as the device was unable to fully fire during functional testing.The investigation is confirmed for the identified nonstandard device issue as the cannula was found detached, nonhomogeneous, and not flared.The investigation is confirmed for the identified detachment of device or device component issue as the cannula was found detached.The root cause for the reported failure to prime, identified failure to fire and identified detachment of device or device component issues are likely due to the condition of the cannula (e.G., detached, nonhomogeneous, and not flared).The root cause for the identified nonstandard device issue is determined to be manufacturing related.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 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: MARQUEE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19474523
• Report Number: 2020394-2024-00760
• Device Sequence Number: 3931092
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: MQ1410
• Device Lot Number: 0001519793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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