MAUDE Adverse Event Report: TERUMO CORP. RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-1011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a radiofrequency catheter ablation, we were unable to pass balloons.We tried multiple times with multiple balloons and guides.There was resistance felt at a usual spot in the guide catheter.Wire was removed and wiped and reinserted.After aborting the procedure and inspecting the run through.014 x 180cm intervention wire it was found that at a transition point on the wire was where everything was getting stuck.This was tested with several balloons, and they all got stuck.We tried a new wire and found that although the transition point could be felt balloons crossed freely.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORP.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 21078606
• Report Number: 21078606
• Device Sequence Number: 8386629
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)270430(10)24517Y
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2024
• Report Date (Section F): 12/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 25-1011
• Device Catalogue Number: TW*AS418XA
• Device Lot Number: 24517Y
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/19/2024