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

Model Number	INS-5915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported they had issues setting up the spin access catheter and was not able to use the instrument due to the sheath breaking.There was no impact on the patient or the procedure.The procedure was reportedly able to be completed with no delay after opening a new spin access catheter.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Therefore, a root cause could not be identified.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.H6: component code "cover" used as "sheath" is not available.

• 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: 17243101
• Report Number: 3007222345-2023-00068
• Device Sequence Number: 17458030
• Product Code: JAK
• UDI-Device Identifier: 00815686021290
• UDI-Public: 00815686021290
• 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
• Report Date (Section B): 06/30/2023

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: 02/25/2023
• Device Model Number: INS-5915
• Device Catalogue Number: INS-5915
• Device Lot Number: 85183200224
• 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: 08/12/2021
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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