MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH; BIOPSY BRUSH

Model Number	INS-5300
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the wires of three (3) of the ins-5300 (always-on tip tracked triple needle brush) were bent at a 90-degree angle near the hub where the brush is deployed.All three were noticed out of the package, prior to use.Two (2) of the wires completely broke and one (1) was still able to be used to complete the procedure.The procedure was delayed by 5 minutes; however, there was no patient or user injury reported due to the issues.This medwatch report is being submitted for the issue with the second ins-5300.The issue with the first ins-5300 is being reported under medwatch 3007222345-2023-00032.The issue with the third ins-5300 is being reported under medwatch 3007222345-2023-00034.
Additional Manufacturer Narrative
The subject devices were not returned for evaluation, as they were discarded by the hospital.No further information was obtained.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report, and to provide information based on the investigation of the returned device.One of the devices was returned for evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the instrument was bent at a sharp angle at the hub.The reported issue was likely caused by damage to the device packaging through distribution, handling, or in storage, thereby causing damage to the device.Veran will continue to monitor field performance for this device.

• Brand Name: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH
• Common Device Name: BIOPSY BRUSH
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center dr.; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17195094
• Report Number: 3007222345-2023-00033
• Device Sequence Number: 12597103
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 07/01/2022
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 03925190620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown