MAUDE Adverse Event Report: TERUMO CORPORATION VISIGLIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G-240-2545A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

An eus-guided (endoscopic ultrasound) biliary rendezvous with ercp (endoscopic retrograde cholangiopancreatography) procedure was being performed.A therapeutic echoendoscope was inserted and the left intrahepatic bile duct was punctured using a 19-gauge needle under endosonographic and radiologic guidance through a transgastric approach.An angled visiglide guidewire was passed anterograde through the needle.The guidewire was retracted.Fluoroscopy revealed that a fragment of the guidewire was retained in the patient¿s liver.An attempt to remove the fragment of wire during the procedure was unsuccessful.The patient was given prophylactic antibiotics.Determination to remove the retained wire will be made in the follow up appointment.

• Brand Name: VISIGLIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 12575996
• MDR Text Key: 274796176
• Report Number: 12575996
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2021,09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G-240-2545A
• Device Catalogue Number: G-240-2545A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 97