MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00514250

Device Problems Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex esophageal ng stent was implanted to treat a stricture in the oesophagus during an oesophageal stent placement procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to stent placement procedure.The initial ultraflex esophageal stent placement procedure was performed on (b)(6) 2015.However, at a later unspecified date, the patient exhibited symptoms and it was noted that the stent had migrated into the stomach.Thus, on (b)(6) 2016, an attempt was made by the physician to remove the implanted ultraflex esophageal stent.Initially, the physician attempted to remove the stent by using rat tooth forceps to grab the suture loop, but the stent suture broke.A snare was then placed around the end of the ultraflex esophageal stent; however, during the attempt to pull the stent out of the patient, part of the stent became detached, leaving a section of the stent inside the patient's esophagus.It was reported that the physician is comfortable leaving the remainder of the broken ultraflex esophageal stent in the patient's esophagus.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5548734
• MDR Text Key: 41918564
• Report Number: 3005099803-2016-00847
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2017
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 17922844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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
• Patient Outcome(s): Required Intervention