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

Catalog Number MAXX-2310

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

The user reported that an esophageal stent broke into several pieces during a routine removal.The stent was telescoped into an additional stent and was caught on the upper esophageal sphincter during removal.The stent was in place for 6 weeks.Implant date was estimated to be on (b)(6) 2014.No lot number was provided.No harm or injury to the pt was reported.

Manufacturer Narrative

Device eval: one device was returned for eval.Since the lot number was not provided, the device history record and complaint database could not be reviewed.The device was visually inspected and the stent had broken into several pieces.The complaint was confirmed.The root cause is attributed to the removal technique.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4005271
• MDR Text Key: 4692967
• Report Number: 1721504-2014-00164
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/26/2014

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: Health Professional
• Device Catalogue Number: MAXX-2310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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