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

Model Number M00565100

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the sigmoid colon during a stent placement procedure performed on an unknown date.Reportedly, the stent was implanted as a bridge to surgery.During the procedure, the physician was able to deploy the stent.Reportedly, the distal end of the stent was in a tortuous anatomy and it was difficult to ¿flow the flight¿.The stent remains implanted and the physician inserted an ileus tube for drainage.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) stent blocked.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.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.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3851962
• MDR Text Key: 4620543
• Report Number: 3005099803-2014-02197
• 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: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• 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
• Patient Age: 82 YR