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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDOMAXX ESOPHAGEAL STENT; PROSTHESIS, ESOPHAGEAL
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MERIT MEDICAL SYSTEMS, INC. ENDOMAXX ESOPHAGEAL STENT; PROSTHESIS, ESOPHAGEAL Back to Search Results
Catalog Number MAXX-2315
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2014
Event Type  malfunction  
Event Description
The user reported that an esophageal stent broke 2cm from the proximal end into two pieces during a routine removal.The stent was implanted four weeks earlier for a bariatric leak.Estimated implant date, (b)(6) 2014.No harm or injury to the pt was reported.
 
Manufacturer Narrative
Device eval: no device is expected to be returned for eval.Since the lot number was not provided, the device history record and complaint database could not be reviewed.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future, this investigation will be reopened and an add'l f/u submitted.
 
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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 Key3999051
MDR Text Key21446905
Report Number1721504-2014-00153
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/13/2014
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 NumberMAXX-2315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/13/2014
Initial Date FDA Received07/09/2014
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 Number1
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