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

Model Number	VB14116
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a biopsy procedure, the connecting tube allegedly detached from the device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one vacora biopsy probe has returned for evaluation.On the visual evaluation of the device, the probe appeared bloody and the syringe assembly was detached from the tubing.No specific anomalies noted.No damage was noted on the tubing and syringe assembly.On the functional evaluation of the probe, the were able to attach and calibrated with the in-house driver without any issue.Then probe was calibrated an additional two times, both times were successful.Therefore, the investigation remains inconclusive, as although the tubing were detached from the probe in the returned device, during the functional evaluation the probe was able to attached and calibrated with the in-house driver without any issue.A definitive root cause for the detachment of device could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a biopsy procedure, the connecting tube allegedly detached from the device.There was no reported patient injury.

• Brand Name: VACORA
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11452399
• Report Number: 2020394-2021-00497
• Device Sequence Number: 19845861
• Product Code: KNW
• UDI-Device Identifier: 00801741000324
• UDI-Public: (01)00801741000324
• 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): 04/20/2021

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: VB14116
• Device Catalogue Number: VB14116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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