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

Model Number	MQK1210
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Fire (2610); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the marquee product is (b)(4).(expiry date: 07/2024).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly had firing problem and it was further reported that the needle was caught in the tissue while trying to withdraw the needle.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the marquee product is bd-santo domingo.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 returned for evaluation.During visual evaluation, the device appeared to have residue and the device was returned in half primed position thus leaving the sample notch in exposed condition.Upon functional testing, the device was able to be fully primed with no issues.The device was further tested by cocking and firing the device 12 times at the 18 mm and 25 mm into a pork shoulder using the automatic and semiautomatic firing options.The device was able to prime and fire properly.All 24 samples were obtained.Therefore, the investigation is unconfirmed for the reported failure to fire issue, as the device was able to fire without issues.However, the investigation is inconclusive for the reported difficult to remove issue, as conditions of use cannot be replicated.A definitive root cause for the alleged failure to fire and difficult to remove issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2024), g3, h6 (method).H11: b5, h6 (device, result, conclusion).H11: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.H3 other text : see h10.
Event or Problem Description
It was reported that during a breast biopsy procedure, the device allegedly failed to fire.It was further reported that the needle was allegedly caught in the tissue while trying to withdraw the needle.There was no reported patient injury.

• 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): UNKNOWN; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12906635
• Report Number: 2020394-2021-02026
• Device Sequence Number: 11971774
• Product Code: KNW
• UDI-Device Identifier: 00801741097263
• UDI-Public: (01)00801741097263
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 02/07/2022

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 Model Number: MQK1210
• Device Catalogue Number: MQK1210
• Device Lot Number: 0001428054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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