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

Model Number	EV14
Medical Device Problem Codes	Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2025).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 an ultrasound-guided breast biopsy procedure through normal density tissue, while removing the needle from the coaxial which is leaved in place in order to place breast tissue marker, the needle allegedly did not came free from the coaxial.A coaxial needle was used.It was further reported that a foreign object was noticed to be stuck in the distal end of the tip of the cutter of the needle which would have stopped it from coming through the coaxial.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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one elevation breast biopsy probe was returned for evaluation.On visual evaluation, the device appeared to have residue throughout.And it was sample tank base was secured to the probe cover insert, and the sample tank basket was noted to be returned.And it was noted that there was an unknown foreign like object at the tip of the needle.Based on ftir, it was noted that the liquid organic material and small diameter shaft as foreign material.And the liquid organic material showed good correlation with fatty acid and alcohol, and the small diameter shaft showed good correlation with polypropylene.Therefore, the investigation for the reported foreign material is confirmed as the material was noted within this device.However, the investigation for the reported difficult to remove is kept as inconclusive as the functional testing was not performed.One electronic photo was provided for review.Photo shows the needle of the device where it shows the tip of the needle has some material stick to it.The material seemed like the plastic material.Therefore, based on the photo review, the reported failure foreign material can be confirmed.However, based on the photo review, the reported failure difficult to remove could not be confirmed.Based on the sample evaluation and photo analysis, the reported foreign material is confirmed, and the reported difficult to remove is kept as inconclusive.A definitive root cause for the alleged difficult to remove and 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: 12/2025), g3, h6 (method).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 an ultrasound-guided breast biopsy procedure through normal density tissue, while removing the needle from the coaxial which is leaved in place in order to place breast tissue marker, the needle allegedly did not came free from the coaxial.It was further reported that a foreign object was noticed to be stuck in the distal end of the tip of the cutter of the needle which would have stopped it from coming through the coaxial.There was no reported patient injury.

• Brand Name: ELEVATION PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16829853
• Report Number: 2020394-2023-00299
• Device Sequence Number: 1931627
• Product Code: KNW
• UDI-Device Identifier: 00801741182396
• UDI-Public: (01)00801741182396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: EV14
• Device Catalogue Number: EV14
• Device Lot Number: 91017721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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