MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR MRI DRIVER; REUSABLE BIOPSY

Catalog Number	DRENCORMR
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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 encor mri driver serial number (b)(6) was received at the zielenople.The encor mri driver was visually inspected upon receipt and was found to be in good overall condition.The script version is 1.25.The device was functionally tested and passed the tests.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported sampling on its own issue.The root cause for reported sampling on its own issue cannot be determined as the problem could not be reproduced.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.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 when tapping the sample button on the encor mri driver, instead of closing the shutter it will take a sample.After completing a clock face, instead of stopping it will continue on around.Having the screen set to take only one sample and holding the sample button on the driver to take only one sample and then lifting your finger it will continue to take a sample in that position, had to disconnect the needle in order for it to stop sampling.Additional information was provided stating that the same facility was using the encor enspire system sn (b)(6) and encor mri driver sn (b)(6) in the same event.The user also stated this issue has occurred at a few different steps - but mostly after administering anesthetic or placing the marker.Once it continued taking the samples after the doctor has finished the 'clock face' (obtained 6 samples) and had taken their finger off the sample button on the driver.Modality used was mri.To stop the procedure encor enspire system was turned off.Even though the needle was inside the patient's breast when this issue occurred, there was no reported patient injury, and no medical intervention was needed for any of the patients.There were no issues reported with the disposables used.

• Brand Name: ENCOR MRI DRIVER
• Common Device Name: REUSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23751259
• Report Number: 2020394-2025-02130
• Device Sequence Number: 21189367
• Product Code: KNW
• UDI-Device Identifier: 00801741086083
• UDI-Public: (01)00801741086083(17)990817
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: DRENCORMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 12/08/2025
• 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