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

Model Number	INS-5905
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Out of the box, the telescoping shaft connect to the handle of the spin access catheter broke off when putting the adapter, guidewire, and catheter together.A new ins-5905 was opened and the procedure was completed.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report and to provide information regarding the investigation of the returned device.G3 was blank in the initial report: date received by manufacturer was 20-jan-2022.The subject device was returned for investigation.The investigator confirmed that the hub disconnected from the telescoping section.The adhesive was visible on the telescoping piece and appeared fully around the shaft.The investigator was able to easily slide the telescoping section back into the hub and it functioned properly.On further review, this malfunction is not considered to be a reportable malfunction.The telescoping piece remains outside of the patient.The risk to the patient is the potential for a minor delay to open a new instrument, which is what occurred in this event.The procedure was able to be completed after a six (6) minute delay to switch to a new instrument.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: 13509737
• Report Number: 3007222345-2022-00006
• Device Sequence Number: 20461582
• Product Code: JAK
• UDI-Device Identifier: 00815686021269
• UDI-Public: 00815686021269
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,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: 85491200806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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