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

Model Number	2747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire detached within the patient.A luge guidewire was selected for use during the procedure.However, the tip of the wire sheared off and had to be left embedded in the liver parenchyma.No further complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.:- the device was not returned for analysis.However, a media was provided by the site and was reviewed by boston scientific medical personnel.The media does not show any evidence of the reported issue.
Event or Problem Description
It was reported that the guidewire detached within the patient.A luge guidewire was selected for use during the procedure.However, the tip of the wire sheared off and had to be left embedded in the liver parenchyma.No further complications were reported.It was further reported via facility medwatch report mw5150887 that tip detachment occurred.Transjugular intrahepatic portosystemic shunt (tips) was performed.A non-boston scientific guidewire 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.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was not returned for analysis.However, a media was provided by the site and was reviewed by boston scientific medical personnel.The media does not show any evidence of the reported issue.

• 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: 18682042
• Report Number: 2124215-2024-07134
• Device Sequence Number: 6144005
• Product Code: DQX
• UDI-Device Identifier: 08714729252337
• UDI-Public: 08714729252337
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 01/16/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/12/2024
• 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: Other
• Patient Sex: Unknown