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

Model Number M00565020

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation result of stent damaged.Investigation result of stent wire broken.Investigation results: a wallflex ¿ duodenal stent and delivery system were returned for analysis.Visual evaluation found the blue outer sheath was kinked.The stent was damaged, and a stent wire was broken.Functional evaluation found the distal end of the sheath retracted past the stent holder when the handle was fully retracted.No other issues were noted with the device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A broken stent wire could potentially catch on the outer sheath and prevent the stent from releasing properly.The broken stent wire of the returned device may have resulted in the reported complaint.The damages noted with the device were consistent with the failed deployment attempts.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 july 28, 2016 that a wallflex ¿ duodenal stent was to be used to treat a gastric outlet obstruction in an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to procedure.According to the complainant, during the procedure, the nurse could not fully deploy the stent.The stent was fully reconstrained on the delivery system and was removed from the patient.The procedure was completed with another wallflex ¿ duodenal 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 the wallflex ¿ duodenal stent was damaged and stent wire 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: 6004647
• MDR Text Key: 56932162
• Report Number: 3005099803-2016-03038
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2016

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: 01/04/2018
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0018768097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• 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