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

Model Number M00516250

Device Problem Device Packaging Compromised (2916)

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

Event Date 02/06/2016

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device has been disposed 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 a wallflex fully covered esophageal rmv stent was to be used in the esophagus during esophageal stent placement procedure performed on (b)(6) 2016.According to the complainant, during unpacking, the device packaging was torn and the sterile seal was compromised.The wallflex esophageal stent was not used inside the patient.The procedure was completed with another wallflex esophageal stent.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: WALLFLEX¿ ESOPHAGEAL
• 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: 5477691
• MDR Text Key: 39639613
• Report Number: 3005099803-2016-00411
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2016
• Device Model Number: M00516250
• Device Catalogue Number: 1625
• Device Lot Number: 17276019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• 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