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

Catalog Number	ECP0110G
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017); Suction Problem (2170); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: one encor probe and partial vacuum assembly were received for evaluation.During visual evaluation, the device appeared to have residue throughout, the aperture appeared to be closed and it was observed that the saline cap was not returned for evaluation.Under microscopic observation, both proximal retaining caps appeared to be cracked.No functional testing due to the condition of the returned device.The dhr review indicates the reported product lot was released on 22/08/2022 with an expiration date of 07/2024.Information provided by the complainant indicates the date of event was 02/07/2024.Therefore, the investigation is confirmed for the identified break as the both retaining caps of the received probe were noted to be broken, the investigation is confirmed for the reported improper or incorrect procedure as the use of expired product were observed and the investigation remains inconclusive for the both suction issue and failure to obtain sample as further functional testing cannot be done due to the returned condition of the device.A definitive root cause for reported suction problem, reported failure to obtain sample and identified break could not be determined based upon the provided information.Labeling review: a review of the bd encor breast biopsy system instructions for use (ifu ¿ bawiu0072, rev.4) determined the product labeling documentation is adequate.Per the encor instructions for use (ifu) how supplied section, the bd encor are supplied sterile for single use only with a use by date (e.G., expiry date).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 breast biopsy through soft density tissue, the suction power of the device allegedly had insufficient vacuum.It was further reported that the tissue allegedly could not be removed.The procedure was completed using another method.There was no reported patient injury.

• Brand Name: ENCOR PROBE
• 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: 20815952
• Report Number: 2020394-2024-01761
• Device Sequence Number: 15692222
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243(11)220822(17)240701(10)VTGU0480
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 11/27/2024

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: 07/01/2024
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTGU0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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: Unknown