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

Model Number M00565060

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the sigmoid colon during a colonoscopy with interventional radiography and stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat an 8-10 cm stricture due to colonic obstruction.Reportedly, the patient¿s anatomy was tortuous.During the procedure, the stent failed to deploy.Reportedly, the white handle detached from the outer sheath.The stent was removed from the patient.The procedure was completed with a different device.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 an mdr-reportable based on investigation results which revealed the returned stent was partially deployed.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Evaluation report of stent partially deployed.A visual examination of the returned device found that the stent was partially deployed by 17mm.It was noted that the outer sheath was detached from the distal handle and the stainless steel shaft was bent.The outer sheath was stretched with kinks for a distance of 130mm at its proximal end and the clear outer sheath was kinked at several locations.During analysis, a restriction was met when an attempt was made to retract the outer sheath and deploy the stent.The shaft was dissected at the proximal end of the clear outer sheath.No issues were noted in movement of the outer sheath along the shaft after the shaft had been dissected.The stent and distal end of the inner lumen were withdrawn from the outer sheath and no issues were noted with their profiles.The inner was kinked and the spacertube had come way from the handle.The proximal end of the outer sheath was dissected longitudinally and it was noted that polytetrafluoroethylene (ptfe) coating had partially peeled away from inside of the outer sheath.Based on the event description and the condition of the returned device, it is likely the noted damages were due to procedural factors such as 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.A search of the complaint database revealed that no similar complaints exist for the specified lot.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: 3916723
• MDR Text Key: 15361481
• Report Number: 3005099803-2014-02426
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2015
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 16597841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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