MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number 2747

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported via facility medwatch report mw5150890 that tip detachment occurred.Transjugular intrahepatic portosystemic shunt (tips) was performed.A gadani wire was placed as a marker in both the right and middle hepatic portal vein.Due to obliteration of periportal fat and heterogenous liver, transhepatic portal was difficult to access.Some injections seemed to be within intrahepatic hematoma.A 182cm luge guidewires were selected for used.Three occurrences where the tip of the guidewire sheared off inside the patient.On two of those occurrences, the physician was able to snare and retrieved the device, while on one occurrence; the tip of the wire had to be left embedded in the liver parenchyma.No patient complications were reported.

• Brand Name: LUGE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18869177
• MDR Text Key: 337257023
• Report Number: 2124215-2024-12384
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729252337
• UDI-Public: 08714729252337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0032176733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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