MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. EnCor Biopsy Probe; Biopsy Instrument

Catalog Number	ECP0110GV
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a biopsy procedure using encor probe device.During the procedure, it was reported that the patient experienced significant bleeding with blood leakage noted at the needle connection site.The procedure was completed using another device.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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.
Event or Problem Description
On (b)(6) 2026, a patient underwent a biopsy procedure using encor probe device.During the procedure, it was reported that the patient experienced significant bleeding with blood leakage noted at the needle connection site.The procedure was completed using another device.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 10gv encor biopsy probe complete sample trap assembly and saline cap were received for evaluation.During visual evaluation, the device was received with the tip protector attached to the needle.The encor biopsy probe had what appeared to be blood residue throughout the entire device.The probe gears appeared to have residue.The probe body was to be rotated, however due to the blood residue no cracks could not be found.No cracks were observed on the probe body.It was observed that the aperture was received partially open.No other anomalies were noted.Prior to functional testing, the probe cannula pathway was cleared.The probe cutter was manually retracted, and a mandrel was inserted into the probe cannula pathway; and tissue was not noted within.Gears were able to move freely, and aperture was able to open without issue.Upon functional testing, an in house encor enspire system was used for functional testing.The probe was loaded into the in house driver and calibrated successfully.A maximum vacuum test was performed with the cutter at the half-sample position and met the minimum specification.A vacuum differential test was also performed and met the minimum specification.The probe was then inserted into a piece of beef, and around-the-clock sampling was conducted.During each sampling cycle, the aperture opened, the sample was cut, and the tissue sample was successfully deposited into the sample tray.The probe successfully obtained six samples.No error messages were displayed on the console during testing, and no unusual noises were noted throughout the evaluation.The probe tip was placed vertically into a beaker of water and vacuum was applied.The water was able to be sucked up into the sample chamber.The probe was removed, and no leaks were identified around the gears or sample chamber/probe connection point.Dried blood particles were noted near the gears of the driver.Therefore, the investigation is confirmed for the reported leak as there is evidence of a blood leak and tracking along the outer housing of the probe, probe gears, and within the cavity/base of the probe body.The root cause could not be determined as the device functioned as intended and the leak could not be replicated.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion) 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 Biopsy Probe
• Common Device Name: Biopsy Instrument
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe 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: 24329944
• Report Number: 2020394-2026-00253
• Device Sequence Number: 5018270
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: ECP0110GV
• Device Lot Number: VTKRG002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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