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

Catalog Number	E4115
Medical Device Problem Codes	Application Program Problem (2880); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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
A 66-year-old female patient underwent a stereotactic breast biopsy procedure using the encor enspire system.During the procedure, encor enspire system unexpectedly entered into reboot mode while the needle was inside the patient's breast.The procedure was performed in an upright position using vertical approach at the cc angle.No buttons were pressed on the encor foot pedal or the encor driver.While the needle was in the patient's breast and the radiologist was preparing to administer additional lidocaine, the technologist believes the radiologist moved the cables out of the way by the needle.Then, the encor enspire system's screen switched to a reboot mode.So, the technologist powered off the encor enspire system and instructed the radiologist to remove the lidocaine syringe and withdraw the needle.Furthermore, the technician had powered the encor enspire system back on and had to reattach the needle and recalibrate.Then, the technician attached the needle and the radiologist advanced the needle back into the patient's breast to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review were not required as the event was not classified as an unexpected event, the investigation did not identify any manufacturing related issues, and no repeat failures were found during the service history review.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.The odor filter is dirty.The manufactures serial label is not at the current revision.The monitor shows a bios screen on bootup with an error message about the date and time not being correct due to a depleted cmos battery.The device was functionally tested and failed the tests due to intermittently sticking vac pin found during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported switched screens reboot mode issue, and the investigation is determined to be confirmed for the identified intermittently sticking vac pin issue.The root cause for reported switched screens reboot mode issue cannot be determined as the problem could not be reproduced.The root cause for identified intermittently sticking vac pin 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 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
A 66 year old female patient underwent a stereotactic breast biopsy procedure using the encor enspire system.During the procedure, encor enspire system unexpectedly entered into reboot mode while the needle was inside the patient's breast.The procedure was performed in an upright position using vertical approach at the cc angle.No buttons were pressed on the encor foot pedal or the encor driver.While the needle was in the patient's breast and the radiologist was preparing to administer additional lidocaine, the technologist believes the radiologist moved the cables out of the way by the needle.Then, the encor enspire system's screen switched to a reboot mode.So, the technologist powered off the encor enspire system and instructed the radiologist to remove the lidocaine syringe and withdraw the needle.Furthermore, the technician had powered the encor enspire system back on and had to reattach the needle and recalibrate.Then, the technician attached the needle and the radiologist advanced the needle back into the patient's breast to complete the procedure.There was no reported 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: 24141737
• Report Number: 2020394-2026-00019
• Device Sequence Number: 18513349
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113(17)401231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/07/2026

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: 12/29/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/15/2026
• 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 Age: 66 YR
• Patient Sex: Female