MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a wallflex ¿ duodenal stent and delivery system was returned for analysis.Visual evaluation found kinks in the blue outer sheath and the stainless steel tube.The blue outer sheath was separated from the device handle.In addition, the inner shaft distal to the stainless steel tube broke.Functional evaluation found the stent failed to deploy but was able to be manually deployed after the device has been dissected.No other issues were noted with the device.The damages noted with the device were consistent with the application of force during deployment.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the event, the most probable root cause classification for the reported failure is operational context.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that an wallflex enteral doudenal stent was used in the duodenum during a stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent failed to deploy and the handle broke.The procedure was completed with another wallflex enteral doudenal 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 fine.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that inner shaft was broken.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 5924241
• MDR Text Key: 53793555
• Report Number: 3005099803-2016-02487
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2016

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: 09/30/2017
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 18465823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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