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	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was successfully used to complete the procedure.During the retrieval of the sample, the device was destroyed and discarded by the hospital.With no device to evaluate, there is insufficient information to investigate the cause of the device failure described in the complaint.This event is being reported in response to an observation from an external inspection.There has been no associated harm attributed to the reported event.We will continue to monitor and trend similar incidents.
Event or Problem Description
Physician found that an always-on tip tracked triple needle brush would not retract fully into the sheath out of the package.Staff was able to retract the tip back into the sheath by stretching the instrument completely straight and pulling apart gently.The device was used to sample and the brush tip was cut for pathology.Procedure was completed.There was no injury or harm to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report.Although the device was discarded by the facility, an investigation was performed based on the complaint information.According to the complaint, the device was able to be retracted while the instrument was stretched out, suggesting there may have been a kink in the sheath preventing retraction.A potential cause for a kinked sheath is too much torque being applied to the device by the user.In this case the sheath was potentially kinked prior to use, possibly in assembly or shipping, since the complaint specifies the problem occurred out of the package.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• 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: 16526618
• Report Number: 3007222345-2023-00012
• Device Sequence Number: 19472164
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 12/16/2022
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 04239191204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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 Age: 76 YR
• Patient Sex: Female