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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: 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 during a biopsy procedure, the driver did not calibrate and returned to the start screen without any command.It was further reported that the pedal calibrated successfully but asked us to remove the driver after collecting the two to three fragments, furthermore, the driver calibrates correctly, however the system returns to the home screen without any commands.Reportedly, the communication issue has been occurred between the driver or foot pedal and the source of communication failure could not be identified.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 videos were provided for review.Therefore, the investigation is inconclusive for the alleged issue as no objective evidence was provided for review.A definitive root cause for the reported system returns to home screen issue could not be determined based upon the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).H11: 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 during a biopsy procedure, the driver did not calibrate and returned to the start screen without any command.It was further reported that the pedal calibrated successfully but asked us to remove the driver after collecting the two to three fragments, furthermore, the driver calibrates correctly, however the system returns to the home screen without any commands.Reportedly, the communication issue has been occurred between the driver or foot pedal and the source of communication failure could not be identified.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: 21407711
• Report Number: 2020394-2025-00193
• Device Sequence Number: 20894165
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113(17)451130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: BR
• PMA/510(K) Number: K111100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: E4115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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