MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AEROMINI TRACHEOBRONCHIAL STENT

Catalog Number AERO815

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a tracheobronchial stent placement within the patient's right main bronchus the delivery catheter tip detached.The stent successfully deployed as desired by the physician.The physician retrieved the catheter tip using a scope and graspers.No additional consequences to the patient have been reported.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: AEROMINI TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: casey hughes ; 1600 w merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 7118269
• MDR Text Key: 95767610
• Report Number: 3010665433-2017-00079
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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: Physician
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: AERO815
• Device Lot Number: IPX2742U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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