MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GEL MARK ENCOR 10G; BIOPSY INSTRUMENT

Model Number	GMUEC10GSS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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.Expiry date: 12/2021.
Event or Problem Description
It was reported that during a breast biopsy marker placement, the device allegedly failed to deploy.The device was removed and replaced with another device.The patient had excessive bleeding due to multiple time removal.Of the device.The patient's current status was unknown.

• Brand Name: GEL MARK ENCOR 10G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12023862
• Report Number: 2020394-2021-01225
• Device Sequence Number: 20025005
• Product Code: NEU
• UDI-Device Identifier: 00801741031854
• UDI-Public: (01)00801741031854
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: GMUEC10GSS
• Device Catalogue Number: GMUEC10GSS
• Device Lot Number: VTEX00506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2021
• Initial Report FDA Received Date: 06/18/2021
• 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: Other