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

Catalog Number	VB14116US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy, when opening the sample notch an unusual sound was heard and allegedly the tubing detached from syringe.It was further reported that the issue occurred after obtaining two tissue samples and the procedure was completed with the samples obtained.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Investigation summary: one vacora biopsy needle was returned for evaluation.The device was returned with the vacuum hose disconnected from the syringe.Dimensional and functional evaluations were performed.Functional testing was performed by re-attaching the syringe hose.The hose was noted to be detached during a sampling cycle.It was noted that the airway for the vacuum of the syringe was blocked through the stylet and would build pressure with no route to escape, thereby forcing the hose off.Therefore, the investigation is confirmed for detachment of device or device component.Per evaluation results, the returned needle was bloody including within the syringe hose.It is likely that blood debris and tissue fragments blocked the vacuum airway contributing to the confirmed issue.It is unknown if procedural and/ or patient factors contributed to the reported event.The definitive root cause could not be determined.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy, when opening the sample notch an unusual sound was heard and allegedly the tubing detached from syringe.It was further reported that the issue occurred after obtaining two tissue samples and the procedure was completed with the samples obtained.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: 7314565
• Report Number: 2020394-2018-00187
• Device Sequence Number: 11212950
• Product Code: KNW
• UDI-Device Identifier: 00801741079351
• UDI-Public: (01)00801741079351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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 Expiration Date: 02/28/2020
• Device Catalogue Number: VB14116US
• Device Lot Number: HUBQ0888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1