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

Model Number M00565050

Device Problems Premature Activation (1484); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the transverse colon during a colonic decompression and stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was being implanted to treat a 3 cm malignant stricture.Reportedly, the patient¿s anatomy was tortuous and was not dilated prior to stent placement.During deployment of the stent, the white handle detached from the outer sheath and the physician inadvertently deployed the stent in the wrong location.The stent remains implanted and there was no attempt made to remove the fully deployed stent.Another wallflex enteral colonic stent was used to complete the procedure.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

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4) for the reported event of stent deployed prematurely.(b)(4) for the reported event of stent positioning/placement issue.The complainant indicated that the device has not been returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 3940214
• MDR Text Key: 4577694
• Report Number: 3005099803-2014-02521
• 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
• Report Date: 06/25/2014

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: 10/04/2015
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 16432666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• 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