MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
Medical Device Problem Codes	Suction Problem (2170); Failure to Obtain Sample (2533); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vacuum assisted breast biopsy procedure through normal density tissue, the needle continues to cut but no sample was taken further.It was further reported that one blue button was allegedly dropped into sample chamber and did not make the needle work.The procedure was completed using another device.There was no reported patient 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, photos and videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2025).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 vacuum assisted breast biopsy procedure through normal density tissue, the needle continues to cut but no sample was taken further.It was further reported that one blue button was allegedly dropped into sample chamber and did not make the needle work.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.Two electronic photos and two electronic videos were provided.The first photo shows the labelling information which verifies/matches with the tw details, the second photo shows that the blue shaft seal cap was noted to be detached and it was shown in sample trap chamber which was partially inserted into the encor probe.The provided two videos shows the encor biopsy probe wrapped up with the plastic cover as the probe undergoes the cycling procedure.Based on the provided photos and videos, the reported device detachment can be confirmed and the other two reported suction issue and failure to obtain sample cannot be confirmed.Therefore, the investigation is confirmed for the reported detachment of device or device component as the provided photo shows that the shaft seal cap was noted to be detached, the investigation is inconclusive for the both failure to obtain sample and suction issue as no objective evidence was shown in the provided photos and videos to support the reported event.It is likely the detached component led to the vacuum issues and inability to obtain samples during the reported event.However, a definitive root cause for the reported failure to obtain sample, suction issue and detachment 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 (device, method).H11: d4 (unique identifier (udi) #), g1, h6 (result, conclusion).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.

• Brand Name: ENCOR BIO PROBE 7G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20703540
• Report Number: 2020394-2024-01706
• Device Sequence Number: 9903752
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)230901(17)250728(10)VTHVA003
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K051158
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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 Expiration Date: 07/28/2025
• Device Catalogue Number: ECP017G
• Device Lot Number: VTHVA003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Female