MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE MODERATE SUPPORT J-TIP; WIRE, GUIDE, CATHETER

Catalog Number H7491213001J0

Patient Problems Hematoma (1884); Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 01/08/2024

Event Type  Injury  

Event Description

Three occurrences where the tip of catheter/guidewire sheared off inside of the patient.On two of those occurrences the interventional radiologist was able to snare the tip and retrieve.On one occurrence the tip that sheared off had to be left embedded in the liver parenchyma.Difficult transhepatic portal access due to obliteration of periportal fat and heterogenous liver.Multiple punctures to get into portal vein."gadani wire" placed as a marker in both the right and middle hepatic portal vein.Jugular access with liverty tips set during access, some injections seemed to be within intrahepatic hematoma.Reference reports: mw5150887, mw5150889, mw5150890.

• Brand Name: LUGE MODERATE SUPPORT J-TIP
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18613161
• MDR Text Key: 334202376
• Report Number: MW5150888
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H7491213001J0
• Device Lot Number: 32176733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male