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

Catalog Number	ECP0110GV
Medical Device Problem Codes	Difficult to Remove (1528); Suction Problem (2170); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Ecchymosis (1818); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2025) 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 stereotaxic guided vacuum assisted breast biopsy procedure, the equipment allegedly generated an error, and it does not make the vacuum.It was further reported that when tried to remove the needle, it gets stuck in the patient's breast, when trying to remove it was seen that it was dragging tissue.Reportedly, the needle got stuck and the tissue broke more.It allegedly caused pain to the patient and increased bleeding.2% lidocaine was administered.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.In that photo, an encor probe's needle was shown in which the aperture was noted to bent and some blood was noted all over the needle.Based on the provided photo, the reported bent can be confirmed and other reported difficult to remove and suction issue cannot be confirmed.Therefore, the investigation is confirmed for the reported bent as the needle shown in the photo was noted to be bent and the investigation is inconclusive for the other two reported failures as no objective evidences were shown in the provided photo to support those reported events.A definitive root cause for the alleged suction problem issue, difficult to remove and bent needle 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.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 which allegedly caused the tissue tear and the patient allegedly experienced pain and had increased bleeding requiring ice compression and two percent lidocaine to be administered.The patient is reported to be stable now.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20551032
• Report Number: 2020394-2024-01632
• Device Sequence Number: 18391435
• Product Code: KNW
• UDI-Device Identifier: 00801741086250
• UDI-Public: (01)00801741086250(11)231027(17)250928(10)VTHXG002
• 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): 01/22/2025

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 Expiration Date: 09/28/2025
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VTHXG002
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown