MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; BIOPSY INSTRUMENT

Catalog Number	DRENCOR
Medical Device Problem Codes	Application Program Problem (2880); Mechanical Jam (2983)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	10/02/2024
Type of Reportable Event	Serious 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 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 stereotaxic guided vacuum assisted breast biopsy procedure, the equipment allegedly generated an error on the screen and stopped working causing the needle to become stuck within the patient's breast.It was further reported that as the needle was being removed, tissue was identified dragging from the needle causing the tissue to further break and patient to feel pain and have increased bleeding requiring 2% lidocane be administered.The patient is reportedly stable and was discharged home.Additional information was received that the error was a vacuum error.
Additional Manufacturer Narrative
H10: manufacturing review: a dhr and manufacturing review was not required as the serial number is unknown.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 error message/stuck needle 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 (serial #, unique identifier (udi) #), e1 (initial reporter city, initial reporter facility name).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 stereotaxic guided vacuum assisted breast biopsy procedure, the equipment allegedly generated an error on the screen and stopped working causing the needle to become stuck within the patient's breast.It was further reported that as the needle was being removed, tissue was identified dragging from the needle causing the tissue to further break and patient to feel pain and have increased bleeding requiring 2% lidocane be administered.The patient is reportedly stable and was discharged home.Additional information was received that the error was a vacuum error.

• Brand Name: ENCOR DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• 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: 21155781
• Report Number: 2020394-2025-00004
• Device Sequence Number: 20747332
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K040842
• 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): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DRENCOR
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown