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

Model Number M00565100

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 09/17/2015

Event Type  Injury  

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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex enteral colonic stent was used in the transverse colon during a colonic stenting procedure performed on (b)(6) 2015.According to the complainant, the stent was placed as a bridge to surgery to treat a 2-3cm stricture caused by regional recurrence of advanced malignancy of the large intestine.Reportedly, the patient's anatomy was slightly tortuous and was not dilated prior to stent placement.During procedure, the wallflex enteral colonic stent was successfully deployed but the stent dislodged from the stricture and moved distally.The physician attempted to use a snare and forceps to retrieve the stent but failed.The procedure was not completed and an urgent transverse colectomy was performed to remove the cancer in the large intestine along with the stent.The patient's condition was reported to be stable after the surgery.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5138667
• MDR Text Key: 27900111
• Report Number: 3005099803-2015-02875
• 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: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0017659450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• 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