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

Model Number	INS-5900
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3007222345-2021-00002
• Device Sequence Number: 3618637
• Product Code: JAK
• UDI-Device Identifier: 00815686021153
• UDI-Public: 00815686021153
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown