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

Model Number	ECP0110GV
Medical Device Problem Codes	Image Orientation Incorrect (1305); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being 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.(expiration date: 12/2023).
Event or Problem Description
It was reported that during a stereotactic breast biopsy procedure through normal density tissue, the needle was allegedly unable to be removed from the patient.It was further reported that, the needle came out with an open aperture.Reportedly, the probe was removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.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 biopsy probe was returned for evaluation.On visual evaluation, the probe appeared to have residue throughout and the device was received with the aperture completely opened condition.An in-house encor enspire system and vacuum assembly was used for functional testing.And it was noted that the related senomark is used for functional testing.The probe was loaded onto the in-house driver and calibrated successfully.The probe was able to rotate around the clock sampling successfully.The marker was able to be removed without any issue.One electronic photo was reviewed.Photo shows the product specifications of the product which was verified and it shows the encor probe needle where the aperture was in open condition.And it was noted that the tip protector was present in the needle.Therefore, based on the photo review, the reported difficult to remove and image orientation incorrect could not be confirmed.Therefore, the investigation for the reported difficult to remove and image orientation issue is kept as inconclusive as the condition of use cant be replicated as the whole device was not returned.A definitive root cause for the alleged difficult to remove and image orientation incorrect could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The information provided by bd represents all of 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 stereotactic breast biopsy procedure through normal density tissue, the needle was allegedly unable to be removed from the patient.It was further reported that the needle came out with an open aperture.Reportedly, the probe was removed from the patient.There was no reported patient injury.

• 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; 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; BR 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16477969
• Report Number: 2020394-2023-00130
• Device Sequence Number: 14252678
• Product Code: KNW
• UDI-Device Identifier: 00801741086250
• UDI-Public: (01)00801741086250
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/30/2023

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 Model Number: ECP0110GV
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VTGNG001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: Female