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

Model Number	INS-5905
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was unable to push the catheter through the adapter.There was a snap and a crease for formed.The physician was unable to feed instruments down the catheter.A second catheter was opened and broke in while the staff was attempting to feed it through the scope.A third catheter was opened and the procedure continued as planned.The broken instrument was not used with a patient.
Event or Problem Description
Clarification regarding the reported event: the second spin access catheter (sac) was opened and was utilized with no issues, until there was a decision to remove the sac from the bronchoscope which resulted in user inflicted damage (broken sac).This medwatch was submitted for the broken sac.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information that was not included in the initial medwatch report and to correct information provided in the initial report.Correction to b3 of the initial medwatch report: the event date was 11-mar-2021.Correction to b4 of the initial medwatch report: date of this report was 13-apr-2021.G3 of the initial medwatch report was blank: date received by manufacturer was 11-mar-2021.On further review, the lot number provided (85494200807) is for an ins-5905, not an ins-5915, which was confirmed by reviewing the customer's sales order history.Corrected product information in d1 and d4.The broken spin access catheter (sac) was not returned for evaluation.The details of the "break" were not provided; therefore, a root cause could not be determined.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: 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: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 11655956
• Report Number: 3007222345-2021-00006
• Device Sequence Number: 3998717
• Product Code: JAK
• UDI-Device Identifier: 00815686021269
• UDI-Public: 00815686021269
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 08/11/2023
• Device Model Number: INS-5905
• Device Catalogue Number: INS-5905
• Device Lot Number: 85494200807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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