MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. EnCor Enspire System; Reusable Biopsy

Catalog Number	E4115
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that the encor driver failed to initialize and stopped detecting the probe while it was attached.There was no patient involvement.Additional details indicate that the encor driver functions intermittently, then stops sensing the needle and returns to the calibrate screen.When the user powers on the encor enspire system, the system boots up and displays the calibration screen.The user attaches the needle and driver to perform calibration, after which the system advances to the sample screen.The user prefers to run several test samples prior to bringing in a patient to ensure the needle is functioning properly.However, during the sample path process, the system unexpectedly returns to the calibration screen.The needle does not move on the driver or lift off at any point.In some instances, the driver does not initialize upon startup, particularly when changing a port.A different needle has been tested on the encor driver.However, issue still persisted.The sales rep confirmed multiple needles were used.Separately, it was reported that prior to procedure, the encor foot pedal's buttons were unresponsive, and exposed wires observed at the base.Additional details indicated that when the foot pedal became unresponsive, the user utilized the encor driver's sample and vacuum buttons to complete the procedure.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.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.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the device was not returned.Investigation summary: the physical device was not returned for evaluation.No photos or video were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported switching screens issue is could not be determined based upon 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.G2, h6 (method, result, conclusion).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 initially reported that the encor driver failed to initialize and stopped detecting the probe while it was attached.There was no patient involvement.Additional details indicate that the encor driver functions intermittently, then stops sensing the needle and returns to the calibrate screen.When the user powers on the encor enspire system, the system boots up and displays the calibration screen.The user attaches the needle and driver to perform calibration, after which the system advances to the sample screen.The user prefers to run several test samples prior to bringing in a patient to ensure the needle is functioning properly.However, during the sample path process, the system unexpectedly returns to the calibration screen.The needle does not move on the driver or lift off at any point.In some instances, the driver does not initialize upon startup, particularly when changing a port.A different needle has been tested on the encor driver, however, issue still persisted.The sales rep confirmed multiple needles were used.Separately, it was reported that prior to procedure, the encor foot pedal's buttons were unresponsive, and exposed wires observed at the base.Additional details indicated that when the foot pedal became unresponsive, the user utilized the encor driver's sample and vacuum buttons to complete the procedure.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 24516088
• Report Number: 2020394-2026-00578
• Device Sequence Number: 13203710
• Product Code: KNW
• 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,Followup
• Report Date (Section B): 07/23/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 07/23/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/11/2026; 07/30/2026
• 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: Unknown