MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN ACCESS CATHETER, 90 DEGREE CATHETER; ENDOBRONCHIAL CATHETER

Model Number	INS-5910
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were three devices (ins-5410, ins-5910, and endobronchial forceps (model number unknown)) associated with the same reported event.Device relationship to the event could not be determined, as a result, a total of three (3) medical device reports associated with the same event are submitted.This report is two (2) of three (3) total reports (reference 300722345-2023-00005 and 3007222345-2023-00007).
Event or Problem Description
During a tissue sampling procedure, a 22ga needle was used inside a spin access catheter (90 degree).A coil break of the 22ga needle occurred while using the needle inside the spin access catheter.No samples were taken before the coil break.A 2-minute delay of the procedure was reported.The forceps were used to obtain samples.After the procedure, the patient had a small pneumothorax.As a precaution, the clinician placed a chest tube.The clinician could not determine whether or not it was associated with the 22 ga needle.The needle may have been extended for a short period of time during the procedure, however it was not used to obtain tissue samples. .
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to correct information provided in the initial medwatch report.Correction to b4 of the initial medwatch report: date of this report was 17-feb-2023.The subject device was not returned for evaluation and the lot number information was not provided.Based on the results of the investigation for the (b)(6) spin access catheter (subject device), the risk documentation provides the following as possible causes of a pneumothorax: 1.Incorrect instrument tip location reported caused by instrument tip location not consistent throughout manufacturing process or not properly quantified for each unit.2.User samples with device in anatomical area (across fissure or pleural wall) that is inappropriate or aggressive in location resulting in minor pneumothorax.3.Incorrect instrument tip location reported due to electromagnetic field for localization disturbed by emi or large metallic object in the field.A pneumothorax is a known risk of the device and the procedure.There is insufficient evidence to determine the root cause of the pneumothorax.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, 90 DEGREE CATHETER
• Common Device Name: ENDOBRONCHIAL 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: 16400782
• Report Number: 3007222345-2023-00006
• Device Sequence Number: 5605343
• Product Code: JAK
• UDI-Device Identifier: 00815686021153
• UDI-Public: 00815686021153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: INS-5910
• Device Catalogue Number: INS-5910
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG