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

Catalog Number	VC10118P
Medical Device Problem Codes	Bent (1059); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional 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.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 a stereotactic breast biopsy, the coaxial cannula was allegedly bent inside the patient.It was further reported that there were enough samples to complete the procedure.Reportedly, the coaxial was unable to be used to guide the marker placement.There was no reported patient injury.
Additional Manufacturer Narrative
After further review of the additional event details provided, the event suggests the device bent inside the patient.It was reported that the device allegedly bent and did not break.There was no reported patient injury.After reassessment of the information, this event was determined to be not mdr reportable.However, an initial mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.Section a through f - 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 a stereotactic breast biopsy, the coaxial cannula was allegedly bent inside the patient.It was further reported that there were enough samples to complete the procedure.Reportedly, the coaxial was unable to be used to guide the marker placement.There was no reported patient injury.

• Brand Name: VACORA COAXIAL
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7509240
• Report Number: 2020394-2018-00658
• Device Sequence Number: 16568011
• Product Code: KNW
• UDI-Device Identifier: 00801741079573
• UDI-Public: (01)00801741079573
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 05/28/2020
• Device Catalogue Number: VC10118P
• Device Lot Number: HUBT0151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 60