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

Model Number M00565050

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

Although the exact patient age was not provided, the patient was reported to be over 18 years of age.(b)(4).The complainant indicated that the device has been 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 that a wallflex colonic stent was to be implanted to treat a malignant stricture in the colon during a colonoscopy with colonic stent placement procedure performed on (b)(6) 2015.Reportedly, the colon was not fully obstructed but the tumor would fully obstruct the colon within a couple weeks without a stent.According to the complainant, during the procedure while the nurse was deploying the wallflex colonic stent it was noted that the sheath was not retracting.The wallflex colonic stent misfired and deployed inside the patient significantly past the stricture.The wallflex colonic stent was removed from the patient with rat tooth forceps.The procedure was completed with a different device.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.

• 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: 5110718
• MDR Text Key: 27022658
• Report Number: 3005099803-2015-02760
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/03/2015

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: Nurse
• Device Expiration Date: 11/16/2016
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0017461015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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