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

Model Number	ECP0110G
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure, needle allegedly bent inside the patient's breast.It was further reported that needle allegedly difficult to remove from the patient.Reportedly the procedure was completed and the needle was removed.There was no reported patient injury.
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, photos and images were provided for review.The investigation of the reported event is currently underway.(expiration date: 11/2023).
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 device appeared to have residue throughout and the aperture was received in a completely open condition.And it was noted that the distal end of the needle was deformed (i.E twisted/bent).Due to the condition of the device, functional testing was not performed.Therefore, the investigation for the identified material deformation is confirmed as the needle was noted to be deformed.However, the investigation for the reported difficult to remove and the material twisted/bent is kept as inconclusive as the functional testing was not performed.Three electronic photos were provided for review.First photo shows the label where the details were verified with the updated information.Second and third photo shows the needle of the encor probe.And it shows the aperture of the needle is slightly narrowed and it seems like the needle is deformed.Therefore, based on the photo review, the identified failure material deformation can be confirmed as the deformed needle is noted.However, based on the photo review, the reported failure difficult to remove could not be confirmed.Therefore, the investigation for the identified material deformation is confirmed as there were proper evident provided.However, the investigation for the reported difficult to remove and material twisted/bent is kept as inconclusive as there were no proper evident provided.Five electronic images were reviewed.First two image shows the image from the stereotactic biopsy probe within the breast.And it shows the probe is bent near its distal end.Another set of images were noted to be taken after the procedure which shows the slightly deformed needle and it was noted that the chamber is mildly narrowed.Last photograph is the photograph of the packaging of the needle.Based on the image review, the identified material deformation can be confirmed as the deformation was noted.Based on the image review, the reported difficult to remove and material twisted/bent could not be confirmed.A definitive root cause for the identified material deformation ,alleged difficult to remove and alleged material twisted/bent 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.D4 (expiration date: 11/2023).H11: section a through f - 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 breast biopsy procedure, needle allegedly difficult to remove from the patient.It was further reported that the device was allegedly bent.The procedure was completed and the needle was removed.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): 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: 15050987
• Report Number: 2020394-2022-00585
• Device Sequence Number: 17518043
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/09/2022

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: ECP0110G
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTFYD001
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• 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