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

Model Number M00565080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used during a colonoscopy with stent implantation procedure in the sigmoid colon performed on (b)(6) 2014.According to the complainant, the stent was being used to treat a lesion located in the sigmoid junction of the colon due to colon cancer.During the procedure, the physician loaded the stent over a guide wire instead of going through a scope because the available scope was shorter than the stent catheter.As the physician was passing the stent over the wire to the desired location, the stent catheter caused a small perforation to the colon.The stent was removed from the patient and the perforation site was closed using approximately 9 to 11 resolution clips.The stent was never deployed or released at all inside the patient.The physician noted that there were no signs of bleeding but the physician was concerned that there may be ¿free air¿ in the patient¿s anatomy.The physician attempted to deploy the stent again over the wire but it was still not successful and the procedure was not completed due to this event.The patient¿s condition at the conclusion of the procedure was reported to be fine.A few days post procedure (exact date unknown), the patient had a tumor resection surgery.The physician reported that the surgery went well, the patient was discharged and is doing well.

Manufacturer Narrative

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: 4247750
• MDR Text Key: 5109598
• Report Number: 3005099803-2014-03689
• 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: 10/28/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2016
• Device Model Number: M00565080
• Device Catalogue Number: 6508
• Device Lot Number: 17096128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2014
• 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