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

Catalog Number	EV10
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 an ultrasound-guided vacuum assisted breast biopsy procedure through hard density tissue, three red lights allegedly came on the sample light, the optional trigger light and the intelligent mode lights while pressing sample button.It was further reported that there was bleeding, resulting in a hematoma.The current status of the patient is unknown.
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 probe received for evaluation.Upon visual evaluation, the probe appeared to be clean and received without protective tubing.The sample tank base was returned and secured to the probe.Both the cutting and transport spindles were in initial position.The main probe assembly was pushed partially forward on the probe cover insert.The cannula grasp didn't appeared to be fastened the probe cover.During functional testing, the probe was loaded into the in-house driver.It calibrated successfully without issue.The probe was calibrated an additional two times, both times were successful.The probe was functionally tested in a chicken breast.The device was tested 6 times.Each time, the probe underwent the following processes: aperture opened, sample cut, and sample deposited into the sample tank.The device collected a sample each time with no issues.The probe was able to obtain 6 samples successfully.No unusual noises were heard during the evaluation.Therefore, the investigation is unconfirmed for the reported failure to cycle as the probe calibrated successfully and obtained all 6 samples with no issues.A definitive root cause for the reported failure to cycle 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: g3.H11: b5, d4 (unique identifier (udi) #), h6 (method, result, conclusion).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 an ultrasound guided vacuum assisted breast biopsy through hard density tissue, three red lights allegedly came on the sample light, the optional trigger light and the intelligent mode lights while pressing sample button.It was further reported that there was bleeding, resulting in a hematoma.However, the current status of the patient is stable now.

• Brand Name: ELEVATION PROBE
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 20608044
• Report Number: 2020394-2024-01659
• Device Sequence Number: 7393223
• Product Code: KNW
• UDI-Device Identifier: 00801741182372
• UDI-Public: (01)00801741182372(11)230928(17)260922(10)91019186
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K192948
• 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): 12/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2026
• Device Catalogue Number: EV10
• Device Lot Number: 91019186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White