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

Model Number INS-5905

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288172420
• Report Number: 3007222345-2022-00006
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686021269
• UDI-Public: 00815686021269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1