MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED FORCEPS; ENDOBRONCHIAL FORCEPS

Model Number INS-0372

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Patient developed a pneumothorax, which required a chest tube and admittance to the hospital after a procedure with the veran spin system and endobronchial instruments.

Manufacturer Narrative

Doctor performed an endobronchial tissue biopsy and took 5 tissue samples during the procedure.No samples were taken with this device, but the device was used during the procedure.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to provide the results of the investigation of the reported event.G3 of the initial medwatch report was blank.The date received by manufacturer was 17-oct-2022.H6: component code for "forceps" not available.As the product was discarded by the facility and the lot number was not provided, there is insufficient information to investigate the failure mode associated with the adverse event.The complaint details indicate that sampling was taking place despite a lack of endobronchial visualization and this caused difficulty for the physician to reach sample locations.Furthermore, multiple veran devices were used during the procedure and it is difficult to assess whether the pneumothorax was caused by any of the veran devices.The associated risk documentation lists a potential cause for pneumothorax is user sampling in anatomical areas that are inappropriate or aggressive in location, and therefore the root cause is mostly associated with user error which may have been caused by complications unrelated to the device.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

Additional information regarding the reported event: the procedure was able to be completed.The pneumothorax was identified after the procedure.Multiple veran instruments were utilized during the procedure.This report was submitted for the (b)(6) always-on tip tracked forceps, 1.8mm od, serrated cup.Two other medwatch reports were submitted for instruments involved in the procedure: 3007222345-2022-00024 and 3007222345-2022-00025.

• Brand Name: ALWAYS-ON TIP TRACKED FORCEPS
• Type of Device: ENDOBRONCHIAL FORCEPS
• 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: 15634946
• MDR Text Key: 302054553
• Report Number: 3007222345-2022-00023
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INS-0372
• Device Catalogue Number: INS-0372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• 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; Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 45 KG