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

Catalog Number	ECP017GV
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after stereotactic procedure, a foreign body was allegedly found in specimen image.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 is currently being performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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.H3 other text : device pending return.
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: one encor probe, removeable probe cover and partial vacuum assembly were received for evaluation along with a specimen cup containing two unknown objects.During visual evaluation, the probe was received with protective tubing and appeared to have residue throughout.Additionally, the device and device components were visually inspected, and no damage was observed.Ftir analysis was performed to determine the material compound of the returned unknown objects, the sample tray, tray cover, and needle protector.Based on the results, the tray and needle protector are consistent with polyethylene (pe) and the tray is a methacrylate blend.The two unknown objects were found to be consistent with human contribution (blood, tissue) saturated in an oily substance (fatty acid such as vitamin a).One electronic photo was provided and reviewed.In that photo, a fluid like substance was noted.Based on the photo review, the reported foreign material cannot be confirmed as the unknown substance shown cannot be determined as the foreign material without the proper evidence.Therefore, based on the evaluation (in which the alleged foreign material was found to be the human contribution(blood, tissue)) and ftir results, the reported event, foreign body in specimen image suspected from the probe, could not be confirmed.Hence, the investigation is unconfirmed for the reported foreign material.A definitive root cause for the alleged foreign material 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: d4 (expiration date: 03/2024).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 after the stereotactic procedure, a foreign body was allegedly found in the specimen image.There was no reported patient injury.

• Brand Name: ENCOR BIO PROBE 7G VERT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17478630
• Report Number: 2020394-2023-00569
• Device Sequence Number: 14137023
• Product Code: KNW
• UDI-Device Identifier: 00801741086298
• UDI-Public: (01)00801741086298
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Catalogue Number: ECP017GV
• Device Lot Number: VTGRC001
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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