MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT

Catalog Number	ECP0110GV
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient was prepped for a mammography breast biopsy procedure through normal density tissue, using the encor bio probe.Prior to the procedure, the biopsy probe had a gooey white substance in the sample notch area.No coaxial was used.The procedure was completed using another device.There was no reported patient contact.
Additional Manufacturer Narrative
H11: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows that an encor probe of a sample notch was place in a package, in which a white unknown plastic particle was seen on the sample notch of the encor probe.Therefore, the investigation is confirmed for the reported device contamination as a white unknown plastic particle was seen on the sample notch of the encor probe.The definitive root cause could not be determined.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.
Event or Problem Description
On (b)(6) 2025, a patient was prepped for a mammography breast biopsy procedure through normal density tissue, using the encor bio probe.Prior to the procedure, the biopsy probe had a gooey white substance in the sample notch area.No coaxial was used.The procedure was completed using another device.There was no reported patient contact.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23130237
• Report Number: 2020394-2025-01557
• Device Sequence Number: 17990363
• Product Code: KNW
• UDI-Device Identifier: 00801741086250
• UDI-Public: (01)00801741086250(11)240312(17)260128(10)VTJPG001
• Combination Product (Y/N): N
• Initial Reporter Country: BD
• 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): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2026
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VTJPG001
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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
• Patient Sex: Unknown