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

Model Number M00565100

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the colon during a colonic stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was to be implanted to treat a malignant stricture.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, it was reported that the stent prematurely deployed causing the stent to be placed in an incorrect location.The fully deployed stent was removed from the patient and 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 stable.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4321280
• MDR Text Key: 15317543
• Report Number: 3005099803-2014-03862
• 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
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 17202734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• 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
• Patient Outcome(s): Required Intervention