MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN ACCESS CATHETER

Model Number	INS-5900
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the start of the case, a catheter (sac 90) was opened to confirm fit in the working channel of the scope.Dr noticed a metal piece on the catheter itself that is not typically there as it was fed into the channel.
Event or Problem Description
There was no impact on the patient or the procedure due to the reported issue.The navigated bronchoscopy was completed with no delay.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report, to provide additional information based on the investigation of the returned device, and additional information regarding the reported event.The subject device was returned for evaluation.It was confirmed there was a loose metal sleeve that inserted into the scope adapter.The metal sleeve was fully contained and able to be slid into place to provide function during insertion into the adapter.It was determined that the metal sleeve was unable to become detached from the device and therefore would not harm the patient.Adhesive was observed on the metal sleeve.According to the investigation, the investigator was unable to determine the reason for the metal sleeve being loose.The investigator determined the issue was possibly due to unusual force being applied while connecting to the adapter.Veran will continue to monitor field performance for this device.D9: date returned to manufacturer is unknown.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: SPIN ACCESS CATHETER
• Common Device Name: CATHETER
• 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: christine hardin ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 11453000
• Report Number: 3007222345-2021-00003
• Device Sequence Number: 4047617
• Product Code: JAK
• UDI-Device Identifier: 00815686021153
• UDI-Public: 00815686021153
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 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: 08/02/2021
• Device Model Number: INS-5900
• Device Catalogue Number: INS-5900
• Device Lot Number: 83554180803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2018
• 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: 75 YR
• Patient Sex: Female