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

Model Number G-240-2527A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Patient in operating room for ercp (endoscopic retrograde cholangiopancreatography) procedure.After cannulation of bile duct, md attempted to exchange sphincterotome over wire.Was unable to pull back the tome and we lost cannulation of the bile duct.When we attempted to pull wire from scope it was unable to be removed as it was stuck.We had to remove the scope entirely from the patient.Upon examination, the guide wire was lodged behind the scope elevator.Attempts to remove it from the scope were unsuccessful initially.Had to get an entirely different scope and open up a new wire in order to continue ercp.Patient was sedated longer than necessary due to equipment malfunction.

• Brand Name: VISIGLIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 16385039
• MDR Text Key: 309651814
• Report Number: 16385039
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2023

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-240-2527A
• Device Catalogue Number: G-240-2527A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White