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

Model Number M00565050

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however ,it was reported that the patient was over the age of 18.The lot number was reported as 18095082, however, this lot number could not be matched to any wallflex colonic device.Therefore, the lot expiration and device manufacture dates are unknown at this time.Reported event of stent wire broken.Reported event of stent unraveled.The complainant indicated that the device remains implanted 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) 2016 that a wallflex enteral colonic stent was implanted to treat a 2 cm malignant stricture in the descending colon during colonoscopy with stent placement procedure performed on (b)(6) 2016.Reportedly, the patient's anatomy was not tortuous.During the procedure, the physician deployed the wallflex enteral colonic stent but it was implanted 2-3 cm distal to the intended location the physician attempted to reposition the stent using a rat tooth forceps but the stent wire broke and began to unravel.The stent was left implanted in the patient as it could not be repositioned or removed.The procedure was completed by placing another wallflex enteral colonic stent 3 cm distal to the first 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 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: 5412310
• MDR Text Key: 37517109
• Report Number: 3005099803-2016-00148
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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