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

Model Number	2747
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch report mw5150888 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 use.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.
Event or Problem Description
It was reported via facility medwatch report mw5150888 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.The reported event information references three occurrences captured in emdr 2124215-2024-07135 (17722511), emdr 2124215-2024-07133 (17722598), and emdr 2124215-2024-07134 (17722711).Follow-up was sent to clarify number of events was sent to the user facility with no response.There is no indication of a 4th occurrence; mdr submitted in error.

• Brand Name: LUGE
• Common Device Name: 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: 18869206
• Report Number: 2124215-2024-12394
• Device Sequence Number: 7786071
• Product Code: DQX
• UDI-Device Identifier: 08714729252337
• UDI-Public: 08714729252337
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown