MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACORA ULTRASOUND BIOPSY PROBE WITH INTEGRATED COAXIAL CANNULA; BIOPSY INSTRUMENT

Catalog Number VB14116US

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.

Event Description

It was reported that during an ultrasound-guided breast biopsy, the tube allegedly came out from syringe while retrieving the second sample.There was no reported patient injury.

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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one vacora biopsy needle was returned for evaluation.The investigation is confirmed based on the as-received condition of the sample.The device was returned with the vacuum hose disconnected from the syringe.The definitive root cause could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current instructions for use (ifu) states: precautions: - the vacora biopsy system should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.Potential complications: - potential complications are those associated with any percutaneous removal/biopsy technique for tissue sample collection.Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.Equipment required: - surgical gloves and drapes directions for use: - depress the "multi-function" button to begin tissue sampling sequence.The sampling process proceeds automatically: a vacuum is created, the outer cannula of the probe is automatically retracted and the tissue is drawn by vacuum into the sampling chamber.The tissue is cut using both side walls of the sampling chamber and the rotating outer cannula of the probe.- remove the probe from the breast and position the sampling chamber in the sterile sample collection container (provided with the probe).- depress the "multi-function" button until the motor engages to expose the tissue in the sampling chamber.- depress the "multi-function" button a third time to close the sample chamber and initiate the "reset" cycle.The breast biopsy procedure may be repeated as needed.

Event Description

It was reported that during an ultrasound guided breast biopsy, the probe tubing allegedly detached from the syringe while retrieving the last tissue sample.It was further reported the procedure was completed with the samples obtained.There was no reported patient injury.

• Brand Name: VACORA ULTRASOUND BIOPSY PROBE WITH INTEGRATED COAXIAL CANNULA
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6974697
• MDR Text Key: 90764591
• Report Number: 2020394-2017-01411
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741079351
• UDI-Public: (01)00801741079351
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: VB14116US
• Device Lot Number: HUBN1261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1