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

Catalog Number	EV12
Medical Device Problem Codes	Suction Problem (2170); Failure to Obtain Sample (2533); Noise, Audible (3273)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a biopsy through hard density tissue, the device allegedly had suction problem.It was further reported that the canula was no longer sucking up the samples, and neither was the haematoma, as the procedure was haemorrhagic.The procedure was completed with another device.Current status of the patient is unknown.
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 return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one elevation biopsy probe was received for evaluation.During visual evaluation, the probe appeared to have blood residue throughout.The sample tank base was secured to the probe cover insert.The main probe assembly was pushed forward on the probe cover insert.The cutting and transport spindle were in initial position.Also heavy presence of blood residue was noted to the blotting papers within the sample tank.No visual anomalies were noted to the device.Upon functional testing, the probe was loaded into the in-house driver.It calibrated successfully without issue.The probe was functionally tested in a chicken breast.The device was tested six 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 what appeared to be blood residue.The probe was able to obtain six samples successfully.No unusual noises were heard during the evaluation.Therefore, the investigation is unconfirmed for the reported suction issue, failure to obtain sample and noise as all 6 samples were obtained without any issues.A definitive root cause for the reported failure to obtain sample, noise and suction problem 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.G3, h6 (device, method, result, conclusion).Section a through f: the information provide 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
On (b)(6) 2025 a patient underwent a biopsy through hard density tissue using elevation probe.During the procedure, the device allegedly had suction problem.It was further reported that the canula was no longer sucking up the samples, and neither was the haematoma, as the procedure was haemorrhagic.The procedure was completed with another device.The current status of the patient is unknown.

• Brand Name: ELEVATION PROBE
• Common Device Name: BIOPSY INSTRUMENT
• 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: 22034287
• Report Number: 2020394-2025-00750
• Device Sequence Number: 21203281
• Product Code: KNW
• UDI-Device Identifier: 00801741182389
• UDI-Public: (01)00801741182389(17)270911(10)91020867
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 Catalogue Number: EV12
• Device Lot Number: 91020867
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown