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 Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the colon during a colonoscopy with stent placement procedure performed on an unknown date.According to the complainant, the stent was used to treat a malignant stricture.Reportedly, the patient¿s anatomy was tortuous.During the procedure, the physician began to deploy the stent but then reconstrained the stent to reposition it.The physician made a second attempt to deploy the stent but the stent would not fully deploy.The partially deployed stent was removed from the patient.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.

Manufacturer Narrative

Evaluation report of stent partially deployed.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A visual examination of the returned device found that the stent was fully mounted.A severe kink was noted in the outer sheath at 45mm from the distal handle.Accordioning of the outer sheath was noted distal to the distal handle.During analysis, a restriction was met when an attempt was made to retract the distal handle and outer sheath.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of the outer sheath along the shaft after the shaft had been dissected.The distal end of the inner lumen and stent were withdrawn from the outer sheath and no issues were noted with their profiles.The proximal end of the inner was withdrawn from the outer sheath and no issues were noted with its profile.The blue section of the outer sheath was dissected longitudinally and it was noted that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.The noted damages were likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A labeling review was performed, and 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 that a wallflex enteral colonic stent was used in the colon during a colonoscopy with stent placement procedure performed on an unknown date.According to the complainant, the stent was used to treat a malignant stricture.Reportedly, the patient¿s anatomy was tortuous.During the procedure, the physician began to deploy the stent but then reconstrained the stent to reposition it.The physician made a second attempt to deploy the stent but the stent would not fully deploy.The partially deployed stent was removed from the patient.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.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4056081
• MDR Text Key: 4807783
• Report Number: 3005099803-2014-02965
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2016
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 16880325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• 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