MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTEM; REUSABLE BIOPSY

Catalog Number	E4115
Medical Device Problem Codes	Break (1069); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, the investigation of the reported event is currently underway.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
A patient underwent a reusable biopsy procedure through encor enspire system, it was reported that during a stereotactic vertical approach procedure while in "sample" mode and they have already begun to sample the patient tissue, the encor enspire system suddenly reverted back to the "start calibration" screen.The user has to remove the needle to recalibrate and re-enter the tissue to complete the procedure.This occurred twice.It was identified that encor enspire system sn: (b)(6), ((b)(4)), encor driver sn: unk, ((b)(4)) and encor foot pedal sn unk ((b)(4)) were used together as a system during this event.There was no patient injury.
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 enspire serial number (b)(6) was received at the bd-bard global service & repair.The encor enspire was visually inspected upon receipt and was found to be in good physical condition.There is a small lip on the left panel that is broken.The ui software is current at 1.07.The control module software is current at 1.34.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported screen reverted back to calibration mode issue and the investigation is determined to be confirmed for the identified broken lip on left panel issue.The root cause for reported screen reverted back to calibration mode issue cannot be determined as the problem could not be reproduced.The root cause for identified broken lip on left panel issue could not be determined based on the provided information.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.G3, h6 (device, component, method, result, conclusion).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 reusable biopsy procedure through encor enspire system, it was reported that during a stereotactic vertical approach procedure while in "sample" mode and they have already begun to sample the patient tissue, the encor enspire system suddenly reverted back to the "start calibration" screen.The user has to remove the needle to recalibrate and re-enter the tissue to complete the procedure.This occurred twice.It was identified that encor enspire system sn (b)(6) (b)(4), encor driver sn (b)(6) (b)(4) and encor foot pedal sn (b)(6) (b)(4) were used together as a system during this event.There was no patient injury.

• Brand Name: ENCOR ENSPIRE SYSTEM
• 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: 23825423
• Report Number: 2020394-2025-02187
• Device Sequence Number: 20100536
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113(17)991231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111100
• 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): 01/13/2026

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: E4115
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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