MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) inner shaft detached.A wallflex¿ enteral colonic stent and delivery system was returned for analysis.Visual examination of the returned device found that the stent was not deployed.The blue outer sheath broke near the handle end of the sheath.The inner shaft was noted to be detached from the end of the stainless steel tube, and the innermost shaft was kinked and stretched.In addition, the stainless steel tube of the handle was also kinked.The complaint as reported is confirmed.It was possible to manually deploy the stent by pulling back the outer sheath.The noted damage to the returned device was consistent with excessive force being applied during deployment and is likely due to anatomical or procedural factors.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.From the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent was to be used to treat a malignant stricture due to colon cancer during a colonoscopy procedure performed on (b)(6) 2016.Reportedly, patient's anatomy was moderately tortuous and had not been dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy.The physician removed the stent from the patient and the procedure was completed with another wallflex enteral colonic 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 reportable based on the investigation result that the inner shaft detached from the end of the stainless steel tube.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 6062191
• MDR Text Key: 58608924
• Report Number: 3005099803-2016-03300
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0019036213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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