MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION DRIVER; BIOPSY INSTRUMENT

Catalog Number	EVDRIVER
Medical Device Problem Codes	Failure to Charge (1085); Device-Device Incompatibility (2919); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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 was received for evaluation.The elevation driver was visually inspected upon receipt and was found to be in good overall condition.Also, the back label lettering is almost rubbed off.The device was functionally tested and failed the test due to driver was unable to be tested as probe was not received and our test probe does connect normally identified during evaluation.Furthermore, the driver will not charge on any charger was found.No other anomalies were identified.Therefore, the investigation is determined to be inconclusive for the reported probe was not flush onto the driver issue, the investigation is determined to be confirmed for the identified driver will not charge issue and the investigation is determined to be confirmed for the identified back label lettering is almost rubbed off issue.The root cause cannot be determined as the device could not be tested for reported probe was not flush onto the driver.The root cause for the identified driver will not charge issue could not be determined based on the provided information.The root cause for the identified back label lettering is almost rubbed off issue could not be determined based on the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 04/2025).H11: section a through f ¿ the information provided 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 during a breast biopsy procedure, the probe was not allegedly able to flush onto the driver.There was no reported patient injury.

• Brand Name: ELEVATION DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• 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: 20225124
• Report Number: 2020394-2024-01431
• Device Sequence Number: 7315560
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• 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: Female