MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY POLYFLEX ESOPHAGEAL STENT SETS; PROSTHESIS, ESOPHAGEAL

Model Number M00514300

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2013

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polyflex esophageal stent was used in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2013.During the procedure, the stent was able to deployed.Following deployment, the physician noted that the proximal flare of the stent was kinked.The physician decided to remove the stent and another stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4) stent kinked.The complainant indicated that the device 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.

• Brand Name: POLYFLEX ESOPHAGEAL STENT SETS
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3573216
• MDR Text Key: 18626177
• Report Number: 3005099803-2014-00223
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2013

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 Expiration Date: 05/31/2018
• Device Model Number: M00514300
• Device Catalogue Number: 1430
• Device Lot Number: 0000013261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• 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