MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLGE; NEEDLE

Model Number INS-5410

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Pneumothorax (2012)

Event Date 09/27/2021

Event Type  Injury  

Event Description

(b)(6) male patient, with a history of copd was having a biopsy performed on a large target in the lll.After the procedure, the patient was scanned and a pneumothorax was noted.A chest tube was place and the patient was sent home on (b)(6) 2021.The patient returned the net day to have the chest tube removed.Patient recovered and was discharged.The biopsy samples indicate the patient has adenocarcinoma.The doctor used ins-5410, flex needle, and ins-5300, triple needle brush, to take the biopsy sample.Since both devices were used to take the sample, the decision was made to report this under the ins-5410, since there is no way to deduce which device was at fault.Note- this report was originally submitted on (b)(6) 2021.A previous employee, christine hardin, submitted on her account and did not realize that the report was sent back with an error.This error occurred due to an incorrect report number used.The report number was put in the wrong location (uf importer report # instead of mfr report.These errors have been corrected for this report and all information contained in this report is accurate at the time of this submission on february 10, 2022.The original report and the esg submission error message reports are all included in this report as evidence that veran submitted during the 30 day window.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report and to correct information provided in the initial report (correction to b3 date of event).G3 of the initial medwatch report was blank: date received by manufacturer was 28-sep-2021.The subject device was not returned for evaluation and the lot information was not provided.There was no allegation of device malfunction of any veran device.A root cause could not be determined.A pneumothorax is a known risk of the device and the procedure.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

This medwatch report was submitted for the ins-5410 always-on tip tracked 22ga anso flexible needle, 15mm l.1.8mm od.It was determined that a separate medwatch report should have been submitted for the ins-5300 always-on tip tracked triple needle brush, 12mm l.1.8mm od.The ins-5300 is being submitted on medwatch 3007222345-2023-00078.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLGE
• Type of Device: NEEDLE
• 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: 13623235
• MDR Text Key: 289763320
• Report Number: 3007222345-2021-00016
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male