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

Catalog Number	E4115
Medical Device Problem Codes	Application Program Problem (2880); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, a pattern was selected, however the unit ignored desired pattern and sampled a full clock rotation, and then device stopped responding.It was further reported that the touchscreen, driver and pedal were all allegedly stopped responding.It has been turned off and back on, driver and pedal detached and reattached and new needle loaded and still it does not respond.Furthermore, we had set the machine to avoid the 7:00 and 9:00 positions.Although the screen showed those positions grayed out, the needle did not avoid these areas when sampling.It ignored the pattern and took a full clock sample instead.After the samples were taken, the needle began pulse as if it was stuck and the unit stopped responding.We used the foot pedal to initiate sampling.After samples were taken and the unit became stuck and stopped responding, we attempted to use both the foot pedal and the sample button on the hand piece to reset the needle and change to marker position but were unsuccessful.We were able to obtain the samples needed, but the machine also sampled two positions that we did not intend to sample.The needle and unit stopped responding after samples were obtained, and we were allegedly unable to switch to the marker placement function.There was no reported patient injury.
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 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.
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 failed to respond/unintended sampling 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) #).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, a pattern was selected, however the unit ignored desired pattern and sampled a full clock rotation, and then device stopped responding.It was further reported that the touchscreen, driver and pedal were all allegedly stopped responding.It has been turned off and back on, driver and pedal detached and reattached and new needle loaded and still it does not respond.Furthermore, we had set the machine to avoid the 7:00 and 9:00 positions.Although the screen showed those positions grayed out, the needle did not avoid these areas when sampling.It ignored the pattern and took a full clock sample instead.After the samples were taken, the needle began pulse as if it was stuck and the unit stopped responding.We used the foot pedal to initiate sampling.After samples were taken and the unit became stuck and stopped responding, we attempted to use both the foot pedal and the sample button on the hand piece to reset the needle and change to marker position but were unsuccessful.We were able to obtain the samples needed, but the machine also sampled two positions that we did not intend to sample.The needle and unit stopped responding after samples were obtained, and we were allegedly unable to switch to the marker placement function.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: 20596959
• Report Number: 2020394-2024-01648
• Device Sequence Number: 6558680
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/08/2025

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: 10/08/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 89 KG