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

Model Number M00565100

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02872 and manufacturer report # 3005099803-2014-02909 for the associated device information.It was reported to boston scientific corporation that two wallflex enteral colonic stents were used in the colon during a stent colonoscopy procedure performed on(b)(6) 2014.According to the complainant, the stents were being used to treat a stricture due to colon cancer and the patient anatomy was tortuous.During the procedure, the physician attempted to deploy a 22x60 wallflex colonic stent (the subject of mfr report# 3005099803-2014-02909) but the stent could not be fully released.The physician reconstrained the stent and attempted to deploy the stent a second time but could not be fully released.The catheter kinked and broke.The stent was reported to have been removed from the patient fully constrained on the delivery system.The physician inserted a 22x90 wallflex colonic stent (the subject of mfr report# 3005099803-2014-02872) and attempted to deploy the stent but the catheter kinked and the stent could not be fully released.The stent was removed from the patient and the procedure was completed with a 22 x 120 wallflex 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 stable.Note: this event has been deemed reportable based on the investigation result that the stent was received partially deployed and the sheath was broken near the clear outer sheath.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Visual examination of the returned device noted that the device was received broken in two.A break was identified on dark blue outer sheath 36cm proximal to the proximal end of the clear outer sheath.The dark blue outer sheath was detached from the distal handle.The outer sheath was kinked, stretched and accordioned at numerous positions along its length.The stainless steel shaft was severely deformed and partial detached at 35mm distal to the proximal handle.The catheter was dissected at the proximal end of the clear outer sheath and the stent and inner sheath were withdrawn.No issues were noted with the profile of the stent and the inner sheath.The outer sheath was dissected longitudinally on both sides of the break and it was noted that the inner layer of (polytetrafluoroethylene) ptfe coating had partially peeled away from the dark blue outer sheath.The stent was received partially deployed by 40mm.Due to the condition of the returned device it was not possible to attempt deploy the stent.No issues were noted with the profile of the stent.The noted damages indicate difficulty was experienced during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: WALLFLEX? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 4061129
• MDR Text Key: 22264819
• Report Number: 3005099803-2014-02909
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2014

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: 12/18/2015
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 16618159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2014
• 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