MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION BREAST BIOPSY SYSTEM DRIVER; REUSABLE BIOPSY

Catalog Number	EVDRIVER
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial 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 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 device requires preventative maintenance.There are no reported device malfunctions.Additional information, during evaluation at the service depot, the elevation driver a broken reset switch, intermittently calibrated and would fail the prime/pierce test, failed the vacuum test, battery slightly pillowed, and the bottom label is missing.There was no patient involvement.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected, and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the elevation driver serial number (b)(6) was received at the bd peripheral intervention.The elevation driver was visually inspected upon receipt and was found to be damaged.The back lid label has indelible ink over the ul mark and the corner by the "ref" box is lifting.There is a "not for human use" label on the right side and an "allison" label on the left side.Neither of these labels are interfering with the bd logos.The bottom label is missing.There is indelible ink with "3.0" and a line near the front of the bottom housing subassembly.The device was functionally tested and failed the tests.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the identified missing bottom label issue.The root cause for reported missing button label issue could not be determined based on the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.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.
Event or Problem Description
It was reported that device requires preventative maintenance.There are no reported device malfunctions.Additional information, during evaluation at the service depot, the elevation driver a broken reset switch, intermittently calibrated and would fail the prime/pierce test, failed the vacuum test, battery slightly pillowed, and the bottom label is missing.There was no patient involvement.

• Brand Name: ELEVATION BREAST BIOPSY SYSTEM DRIVER
• Common Device Name: REUSABLE 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: 23690947
• Report Number: 2020394-2025-02056
• Device Sequence Number: 9071790
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: EVDRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown