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

Model Number	MQ1413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The events are part of a retrospective study.Hemorrhage requiring intervention is captured.As the lot numbers for the devices were not provided, a manufacturing review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported events is inconclusive.Based upon the available information, the definitive root cause for these events is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.On the ones where one product has infection and one has bleeding and one has something else, then you will need to specify which device and patient codes go to which products.
Event or Problem Description
It was reported in a post-market clinical follow-up survey on biopsies, two patients experienced hemorrhage with complications.The current patients' status is unknown.

• Brand Name: BARD MARQUEE DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10210118
• Report Number: 2020394-2020-04101
• Device Sequence Number: 19434109
• Product Code: KNW
• UDI-Device Identifier: 00801741097140
• UDI-Public: (01)00801741097140
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MQ1413
• Device Catalogue Number: MQ1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention