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

Catalog Number MAXX-2310

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2016

Event Type  malfunction  

Event Description

The device never reached the patient since it would not pass over the guardwire used to guide the shunt.

• Brand Name: ENDOMAXX
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 6033725
• MDR Text Key: 57633894
• Report Number: 6033725
• 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: 08/02/2016

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: Unknown
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: MAXX-2310
• Device Lot Number: E981536
• Other Device ID Number: (01)00884450093122
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES