MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00514200

Device Problems Leak/Splash (1354); Torn Material (3024)

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

Event Date 07/04/2017

Event Type  malfunction  

Event Description

Patient had stent placed.Patient found with gastric fluid in chest tube.Esophagram performed to determine source of leak, but was inconclusive.Physician opted to take the patient back for redo of esophageal stent approximately 2 days later.Removed stent found to have significant tear.Stent replaced and patient recovered.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6857887
• MDR Text Key: 85796591
• Report Number: 6857887
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/11/2017
• Device Model Number: M00514200
• Device Lot Number: 18288365
• Other Device ID Number: 23MM X 105MM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other