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

Model Number INS-5900

Device Problems Material Separation (1562); Insufficient Information (3190)

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

Event Date 01/27/2021

Event Type  malfunction  

Event Description

After taking forcep and 22 ga needle samples, the doctor switched to the second target lesion and a piece of plastic was discovered in the patients airway.The catheter was removed and a long thin piece of plastic was still attached to it.Device has not been returned for evaluation.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial report, to provide additional information regarding the event (b5) and additional information based on the evaluation and investigation of the returned device.The subject device was returned for evaluation.The long, thin piece was determined to be the inner lining of the catheter that appeared to have been scraped off by a needle.The issue most likely occurred during insertion of the needle into the catheter with the needle extended.The piece of the inner lining was still attached to the device.There were no loose components.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.

Event Description

Correction to b5 of initial medwatch report: "cathester" should be "catheter".There was no impact on the patient or the procedure due to the reported issue.The procedure was completed with no delay.

• Brand Name: SPIN ACCESS CATHETER BIOPSY GUIDE
• Type of Device: BIOPSY CATHETER
• Manufacturer (Section D): 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: 11383299
• MDR Text Key: 242729038
• Report Number: 3007222345-2021-00002
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686021153
• UDI-Public: 00815686021153
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: INS-5900
• Device Catalogue Number: INS-5900
• Device Lot Number: 84696190926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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
• Patient Outcome(s): Other