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

Catalog Number	EVDRIVER
Medical Device Problem Codes	Break (1069); Contamination (1120); Nonstandard Device (1420); Suction Problem (2170); Ambient Temperature Problem (2878); Application Program Problem (2880); Material Twisted/Bent (2981); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a biopsy procedure using ev driver.During the procedure, it was reported that the elevation device allegedly had vacuum seal punctured.It was further reported that the label was allegedly removed and missing from the device.There was no patient contact.
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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: manufacturing review: this event is determined to be expected.A potential manufacturing related issue was identified, therefore the device history records have been reviewed and determined the lot met all release criteria.Investigation summary: the elevation driver serial number (b)(6) was received at the bd-bard global service & repair.The elevation driver was visually inspected upon receipt and was found to be damaged.The sefar nitex filter is punctured, driver locking bridge not present.There is dried blood in the crevasses between the top and bottom housing subassembly in the tank area.The top housing subassembly will be replaced.The charger and charger power supply were not returned.The device was functionally tested and failed the vacuum test and the flat ribbon cable from the power pcb is bent at the standoff where the top and bottom housing subassembly meet found during evaluation.The temperature indicator is activated.The software is version 2.5.1 and needs upgraded.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported device punctured seal issue, the investigation is determined to be confirmed for the identified driver locking bridge not present issue, the investigation is determined to be confirmed for the identified dried blood in the crevasses between the top and bottom housing subassembly in the tank area issue, the investigation is determined to be confirmed for the identified failed the vacuum test issue, the investigation is determined to be confirmed for the identified temperature indicator activated issue, the investigation is determined to be confirmed for the identified flat ribbon cable from the power pcb is bent issue, the investigation is determined to be confirmed for the identified dent battery issue and the investigation is determined to be confirmed for the identified outdated software is version 2.5.1 issue.A definitive root cause for reported device punctured seal issue was determined to be due to an object forced through the sefar nitex filter identified during evaluation.The root cause for identified driver locking bridge not present issue could not be determined based on the provided information.The root cause for identified dried blood in the crevasses between the top and bottom housing subassembly in the tank area issue could not be determined based on the provided information.The root cause for identified failed the vacuum test issue could not be determined based on the provided information.The root cause for identified temperature indicator activated issue could not be determined based on the provided information.The root cause for identified flat ribbon cable from the power pcb is bent issue was determined to the s&r assembly process.The root cause for identified outdated software is version 2.5.1 issue could not be determined based on the provided information.The root cause for identified dent in battery issue was determined to the s&r assembly process.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.D4 (unique identifier (udi) #), g2, g3, h5, h6 (device, component, method, result, conclusion), h8.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
A patient underwent a biopsy procedure using ev driver.During the procedure, it was reported that the elevation device allegedly had vacuum seal punctured.It was further reported that the label was allegedly removed and missing from the device.There was no patient contact.

• 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: 23023378
• Report Number: 2020394-2025-01466
• Device Sequence Number: 15878560
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365(11)221017(17)401231
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 11/17/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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