MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION 14G PROBE; BIOPSY INSTRUMENT

Model Number	EV14
Medical Device Problem Codes	Failure to Cycle (1142); Difficult to Remove (1528); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure through fatty density tissue, the device allegedly failed to close.It was further reported that the needle was allegedly difficult to remove from the tissue.The procedure was completed using another device.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 return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 02/2023.Device pending return.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure through fatty tissue, the device allegedly failed to cycle.It was further reported that the needle was allegedly difficult to remove from the tissue.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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.One elevation breast biopsy probe was returned for evaluation.On visual evaluation, the probe appeared to have residue throughout and the transport spindle was in initial position while the cutting spindle was retracted partially.The sample tank basket was not returned.Prior to functional testing, the cutting cannula was retracted completely, and a mandrel was inserted into the cannula; no tissue was noted within.On functional evaluation, the probe was loaded into the in-house driver and calibrated successfully and tested in a chicken breast.The device was tested for six times.The probe was able to obtain six samples successfully.It was noted that samples 1-3 were deposited into the sample tank basket with a slight delay.However, samples 4-6 had to be retrieved using a mandrel.No unusual noises were heard during the evaluation.Therefore, the investigation is confirmed for the identified failure to obtain sample issue as there was a slight delay in getting the samples into the sample tank basket.Although, the probe was loaded into the in-house driver and calibrated successfully.The investigation is inconclusive for both the reported failure to cycle and difficult to remove as the incomplete device components were returned for evaluation and the condition of use cannot be replicated in the laboratory condition.A definitive root cause for the reported failure to cycle, difficult to remove and identified failure to obtain sample issues 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.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.

• Brand Name: ELEVATION 14G 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: 16501683
• Report Number: 2020394-2023-00162
• Device Sequence Number: 3354108
• Product Code: KNW
• UDI-Device Identifier: 00801741182396
• UDI-Public: (01)00801741182396
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/17/2023

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: 91015067
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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