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

Catalog Number	VB10118
Medical Device Problem Codes	Failure to Cycle (1142); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review 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.Expiry date: 11/2020.
Event or Problem Description
It was reported that during a biopsy of the thigh muscle, the probe allegedly stopped cycling while inside the patient, and the device allegedly was unable to be removed from the patient.It was further reported that the device was troubleshot while inside the patient and began working again.The device was then able to be removed from the patient and the tissue sample was obtained from the needle.There was no reported patient injury.

• Brand Name: VACORA BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7912100
• Report Number: 2020394-2018-01798
• Device Sequence Number: 13902665
• Product Code: KNW
• UDI-Device Identifier: 00801741079313
• UDI-Public: (01)00801741079313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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 Catalogue Number: VB10118
• Device Lot Number: HUCN3198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1