MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDOMAXX; PROSTHESIS, ESOPHAGEAL

Lot Number E1005053

Device Problems Detachment Of Device Component (1104); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

Event Type  malfunction  

Event Description

While the surgeon was removing an endomax esophageal stent , the stent unraveled and the removal cord came off of the stent.The stent continued to unravel/separate as it was removed piece-by-piece (6 pieces).There was no harm to the patient.Another stent was placed without difficulty.The stent pieces were returned to merit medical for evaluation.

• Brand Name: ENDOMAXX
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 6894058
• MDR Text Key: 87373412
• Report Number: 6894058
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017,09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: E1005053
• Other Device ID Number: MAXX-2315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR