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

Model Number EVDRIVER

Device Problems Contamination (1120); Failure to Prime (1492); Self-Activation or Keying (1557); Failure to Calibrate (2440); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a device history record 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 sample was returned for evaluation.The elevation was visually inspected upon receipt and received fully discharged with crack on bottom housing in the area for the housing back screw, and the large gap was found between the back lid and housings.It was found a mark at the inner surface of driver top housing, which is indicating some substance get into device, and the mechanical module was noted to be contaminated.Further, the charger received functional without visual defects, with power supply and eu adapter, and the software version of 3.0 is found.The device was functionally tested and passed the calibration procedure as prime, pierce and sample button start to glow green, but however failed the tests as device does not respond to any button press.The device also failed the probe recognition test as the device activates itself when connected to a phantom probe and on all types of probes due to the corrosion at keypad flex and main pcb keypad socket noticed identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device failure to calibrate.The investigation is determined to be confirmed for the identified self-activation as the device activates itself during evaluation.The investigation is also determined to be confirmed for the identified failure to prime and failure to fire as the device's prime and pierce button failed to respond, and the investigation is also confirmed for the identified contamination issue.The root cause for the reported failure to calibrate cannot be determined as the problem could not be reproduced.The root cause for the identified self-activation issue was determined to be the corrosion at keypad flex and main pcb keypad socket noticed identified during evaluation.The root cause for the identified failure to prime issue is unknown.The root cause for the identified failure to fire issue is unknown.The root cause for the identified contamination issue is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 12/2026).

Event Description

It was reported that during a biopsy procedure, the device allegedly failed to calibrate.There was no patient contact.

• Brand Name: ELEVATION DRIVER
• Type of Device: 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: 16495822
• MDR Text Key: 311096505
• Report Number: 2020394-2023-00153
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K192948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVDRIVER
• Device Catalogue Number: EVDRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1