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

Model Number M00565120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2014

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 stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a colonic stricture.Reportedly, the patient¿s anatomy was severely tortuous and was not dilated prior to stent placement.During the deployment of the stent, the handle detached from the outer sheath.The physician attempted to reconstrain the stent; however, the stent was unable to be reconstrained completely.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 ¿good.¿.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18 reported event 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 onto the device.The outer sheath was detached from the distal handle and the stainless steel handle was bent.The outer sheath was accordion at its proximal end and the blue outer sheath was kinked at its distal end.It was also noted that the outer sheath was partially covering the tip.During analysis a restriction was met when an attempt was made to retract the outer sheath by hand 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of the outer sheath along the shaft after the shaft had been dissected.The stent and distal end of the inner lumen were withdrawn from the outer sheath and no issues were noted with their profiles.The proximal end of the outer sheath was dissected longitudinally and it was noted that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.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification 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 search of the complaint database revealed that no similar complaints exist for the specified batch.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 sigmoid colon during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a colonic stricture.Reportedly, the patient¿s anatomy was severely tortuous and was not dilated prior to stent placement.During the deployment of the stent, the handle detached from the outer sheath.The physician attempted to reconstrain the stent; however, the stent was unable to be reconstrained completely.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 ¿good.¿.

• 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: 3687702
• MDR Text Key: 4241747
• Report Number: 3005099803-2014-01371
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/24/2014

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: 03/27/2015
• Device Model Number: M00565120
• Device Catalogue Number: 6512
• Device Lot Number: 15980190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 03/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• 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