MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Encor Bio Probe 7G; Biopsy Instrument

Catalog Number	ECP017G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a vacuum assisted breast biopsy procedure using the encor biopsy system with the encor biopsy probe.During the procedure, while using the device on a patient, the patients pectoral muscle tissue was injured, resulting in bleeding.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample has not been 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) are 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.Section a through f: the information provide by bd represents all 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: Encor Bio Probe 7G
• Common Device Name: Biopsy Instrument
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): AUSA Medical Devices Pvt Ltd; 15b bommasandra indl area; hosur road, attibele hobli; anekal taluk, bangalore 560 9 99; IN 560 999
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50852710
• Report Number: 2020394-2026-02786
• Device Sequence Number: 13275161
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(17)270801(10)VTKV0477
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ECP017G
• Device Lot Number: VTKV0477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown