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

Catalog Number	E4115
Medical Device Problem Codes	Application Program Problem (2880); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the serial 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.H11: 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
It was reported that during a biopsy procedure, after the first sample was taken and going for the second sample, the system had allegedly displayed an error message.It was further reported that after the first initial sample was executed, a core was provided.Furthermore, there were no instructions given on the screen to clear the error, so they had to turn off the system mid-biopsy.Moreover, the tech and nurse checked the cannisters and all areas for kinks/loose connections and could not find anything.In addition, the probe was reconnected to the driver and then the biopsy was completed with no issues afterwards.Apparently, the serial number ¿0¿ of enspire system was rubbed off so this letter/number could be a ¿d¿.Evidently, additional review of the label revealed that the serial number as well as the safety information was allegedly blurred and not legible.There was no patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record and manufacturing review was not required as the device was not returned.Investigation summary: the physical device was not returned for evaluation.One photo of encor enspire was provided by the customer and reviewed.In the photo enspire system label was shown which is blur and the information in the label was not clear.No other visual anomalies were noted of the internal component.Based on the review, the investigation is determined to be confirmed for the reported illegible label issue and the investigation is determined to be inconclusive for the reported system error code.A definitive root cause for the system error code/ illegible label issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method) h11: h6 (result) h11: 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 reported that during a biopsy procedure, after the first sample was taken and going for the second sample, the system had allegedly displayed an error message.It was further reported that after the first initial sample was executed, a core was provided.Furthermore, there were no instructions given on the screen to clear the error, so they had to turn off the system mid-biopsy.Moreover, the tech and nurse checked the cannisters and all areas for kinks/loose connections and could not find anything.In addition, the probe was reconnected to the driver and then the biopsy was completed with no issues afterwards.Apparently, the serial number (b)(4) of enspire system was rubbed off so this letter/number could be a ¿d¿.Evidently, additional review of the label revealed that the serial number as well as the safety information was allegedly blurred and not legible.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: 21053634
• Report Number: 2020394-2024-01937
• Device Sequence Number: 8153452
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113(17)130115(10)DYXAF012R
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 12/05/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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: Female