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); Corroded (1131); Suction Problem (2170); Device Markings/Labelling Problem (2911); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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 ferrosan medical devices sp z o.O.The elevation driver was visually inspected upon receipt and was found to be not in normal condition.Also, driver received with punctured and contaminated sefar nitex filter and there are pen marks on the buttons and charging indicator.The label on the back lid is damaged and blurred.Back lid latch and bottom housing are also broken.Charger and power supply are not included, device received only with two adapters.The contamination found inside the device and signs of corrosion on main pcb and power pcb flex.Mechanical module was covered with body fluids.The device was functionally tested and not possible to perform functional tests and due to damage on device, the device entered into an error state, however, due to contamination found inside the vacuum system, the reported vacuum issue got confirmed during evaluation.Furthermore, the reason for lack of functionality of the driver is flooding and corrosion occurring on the pcb components.After charging, the leds in the sample button glow red constantly and no probe logs in device memory.After connecting to the tester's device went into failure mode.The software version 3.0 is found.The water indicator got activated, therefore power pcb, battery and vacuum pump need to be updated.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported device has a suction issue, and the investigation is determined to be confirmed for the identified device entered an error state issue.The investigation is determined to be confirmed for the identified punctured sefar nitex filter, the investigation is determined to be confirmed for the identified contamination inside the device, the investigation is determined to be confirmed for the identified label on the back lid is damaged and blurred, the investigation is determined to be confirmed for the identified signs of corrosion on main pcb and power pcb flex and the investigation is determined to be confirmed for the identified water indicator activated.The root cause for reported device has a suction issue was determined to be contamination found inside the vacuum system identified during evaluation.The root cause for the identified device entered an error state issue could not be determined based on the provided information.However, driver is flooding and corrosion occurring on the pcb components can potentially contribute to the identified driver error state issue.The root cause for identified punctured sefar nitex filter issue could not be determined based on the provided information.The root cause for identified contamination inside the device issue could not be determined based on the provided information.The root cause for identified label on the back lid is damaged and blurred issue could not be determined based on the provided information.The root cause for identified signs of corrosion on main pcb and power pcb flex issue could not be determined based on the provided information.The root cause for identified water indicator activated 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.H11: 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 prior to a biopsy procedure, the device allegedly had a suction issue.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: 21522726
• Report Number: 2020394-2025-00252
• Device Sequence Number: 20916646
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 08/31/2025
• Device Catalogue Number: EVDRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/05/2025
• 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