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

Catalog Number	ECP0110G
Medical Device Problem Codes	Dull, Blunt (2407); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H11: 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
It was reported that prior to a stereotactic guided vacuum-assisted breast biopsy through normal tissue density, the device allegedly had fuzz ball of some sort of plastic.No coaxial was used and the procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to a stereotactic guided vacuum-assisted breast biopsy through normal tissue density, the device allegedly had fuzz ball of some sort of plastic.No coaxial was used and the procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: an electronic photograph was submitted and evaluated.The image depicts an encor probe encased in protective tubing and vacuum tubing are positioned within an open box behind its labeled information, which has been verified and corresponds with the trackwise details.Following the review of the photograph, the reported failure cannot be confirmed.One 10g encor biopsy probe, complete sample tray assembly and removable probe cover were received for evaluation.During visual evaluation, the probe appeared to be clean.The probe body was rotated to identify any cracks.No cracks were observed on the probe body.The probe gears appeared to be clean.It was observed that the aperture was received closed.The needle protector appeared to have skiving.An unknown material was noted to the distal tip of the needle.Skiving was also noted to both sides of the needle protector; the needle was also noted to be dull.No functional testing due to the nature of the complaint.Therefore, the investigation is determined to be confirmed for the reported device contamination as an unknown material was noted to the distal tip of the needle and the investigation is determined to be confirmed for the identified dull, blunt as the needle was noted to be dull.The definitive root cause could not be determined based on the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: 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 AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21076926
• Report Number: 2020394-2024-01943
• Device Sequence Number: 8386056
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243(11)240430(17)260128(10)VTJPD002
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: ECP0110G
• Device Lot Number: VTJPD002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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