MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION PROBE; DISPOSABLE BIOPSY

Catalog Number	EV10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
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 of 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 on (b)(6) 2025, a patient underwent a biopsy procedure using the elevation instrument.Prior to the procedure, it was observed that there was a piece of metal mixed in.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one sealed elevation biopsy probe for evaluation.During visual evaluation, the lot sample was inspected thoroughly.No anomalies were observed throughout the sealed lot sample.During microscopic and functional testing, the sealed lot sample was partially unsealed under microscopic observation.The tyvek was gently peeled from the outer tray, with every angle of the package examined microscopically; no anomalies were observed.The inner tray was then removed and inspected under the microscope, with no anomalies observed.The outer tray was lightly rattled to check for irregularities, but none were found.The device was carefully removed from the outer tray and examined microscopically; no anomalies were noted throughout.The outer tray was placed under x-ray examination.No anomalies were observed during the inspection.Therefore, the investigation is unconfirmed for the reported material fragmentation issue as no anomalies were noted to the returned device during the inspection.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D1, e1, g3, h6 (component, 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.
Event or Problem Description
On (b)(6) 2025, a patient was prepped for biopsy procedure using the elevation instrument.Prior to the procedure, it was observed that there was a piece of metal mixed in.There was no patient contact.

• Brand Name: ELEVATION PROBE
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22641581
• Report Number: 2020394-2025-01137
• Device Sequence Number: 17459726
• Product Code: KNW
• UDI-Device Identifier: 00801741182372
• UDI-Public: (01)00801741182372(11)240910(17)250806(10)91020784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192948
• 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): 01/14/2026

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: 08/06/2025
• Device Catalogue Number: EV10
• Device Lot Number: 91020784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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