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

Model Number GMUEC10GSS

Device Problem Positioning Failure (1158)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/13/2021

Event Type  Injury  

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 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
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12023862
• MDR Text Key: 257168236
• Report Number: 2020394-2021-01225
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741031854
• UDI-Public: (01)00801741031854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GMUEC10GSS
• Device Catalogue Number: GMUEC10GSS
• Device Lot Number: VTEX00506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other