MAUDE Adverse Event Report: LAKE REGION MEDICAL WALLSTENT SUPER STIFF GUIDEWIRE

Device Problem Difficult To Position (1467)

Patient Problems Abdominal Pain (1685); Nausea (1970); Abdominal Distention (2601); Bowel Perforation (2668)

Event Date 10/31/2016

Event Type  Injury  

Event Description

An (b)(6) admitted for elective gi endoscopy with colonic stent placement for sigmoid color adenocarinoma.The pt was taken to the operating room on (b)(6) 2016 and had a flexible sigmoidoscopy under general anesthesia, with placement of the colonic stent.Significant lumenal narrowing was noted at 30cm and a wire was passed through the stricture under fluoroscopy.A balloon dilatation was completed and a colonic bare metal wall stent was inserted.The practitioner noted difficulty with kinking of the balloon/guide wire during the procedure.Postprocedure the pt complained of nausea and periumbilical pain.On (b)(6) 2016, a firm and distended abdomen was noted with radiological findings consistent with a large pneumoperitoneum with associated dilated loops of large and possibly small bowel to the level of a partially collapsed sigmoid stent is concerning for a large bowel obstruction with bowel perforation.The pt was taken urgently to the operating room for a exploratory laparotomy; sigmoid resection for perforated rectosigmoid mass.The stent has been perforated through and through the actual mass.Pt was discharged to home on (b)(6) 2016.

• Brand Name: WALLSTENT SUPER STIFF GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine dr.; chaska MN 55318
• MDR Report Key: 6165920
• MDR Text Key: 62210566
• Report Number: MW5066623
• Device Sequence Number: 1
• Product Code: MQR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 64