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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation, as it was disposed of by the hospital staff.A similar complaint for which the device was returned confirmed that the triple needle brush was slightly extended (<1mm) beyond the end of the sheath.The sheath was measured and found to be within specification at 1104mm.Since the failure mode for that complaint was not caused by a short sheath, other component dimensions or assembly errors were potential causes for the brush tip to be exposed.The length of the pull wire that connects the push needle in the handle to the triple needle brush may have been too long.A definitive root cause for the reported issue could not be determined.
Event or Problem Description
When the doctor opened the subject device (ins-5300) from the packaging, it was noted that the triple needle brush was already deployed, and the instrument did not have the clear protective piece of the tip.The needle would not fully retract when the doctor attempted to retract the brush.This report is being submitted for the triple needle brush not fully retracting.There was no harm to the patient or user.The intended procedure was able to be completed after a minor delay of two (2) minutes.

• 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; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17627192
• Report Number: 3007222345-2023-00079
• Device Sequence Number: 6135681
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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: 08/03/2023
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 04617200717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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