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

Model Number	EV14
Medical Device Problem Codes	Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation of the reported event is currently underway.(expiry date: 11/2020).
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the device allegedly failure to obtain sample.A coaxial needle was used and the procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the device allegedly failure to obtain sample.A coaxial needle was used and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed and this lot met all release criterial.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one elevation biopsy probe was returned for evaluation.On visual evaluation , the device appeared to have blood residue and the gears and cannula were in the initial position.And it was noted that aperture was received closed and the sample tank was tightly and correctly positioned.And it was further noted the expiry date is mislabeled.The probe was loaded into the driver and calibrated successfully.On functional evaluation , the device was tested in chicken breast for 6 times.The probe was able to obtain 6 samples.However , two samples among 6 were not deposited in the sample basket.The probe was taken off the driver and a mandrel was used to clear out the samples from the cutter.All 6 samples were obtained with the smart mode activated.Therefore , the investigation for the identified filling is confirmed as 2 samples among 6 were not deposited into the sample basket.However , the investigation for the reported failure to obtain samples is kept as inconclusive as the identified issue may contributed to the reported event.Therefore , the investigation for the reported expiry product is kept as inconclusive as the date of event is not provided.A definitive root cause for the alleged failure to obtain samples and identified filling issue , expiry product 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.H10: d4 (expiry date: 11/2020),.

• Brand Name: ELEVATION PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12300778
• Report Number: 2020394-2021-01465
• Device Sequence Number: 3761153
• Product Code: KNW
• UDI-Device Identifier: 00801741182396
• UDI-Public: (01)00801741182396
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 91009576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 70