MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved device was used during a complex right coronary chronic total occlusion (cto) percutaneous coronary intervention (pci).Right femoral access was with a 7 french 45 cm pinnacle destination ccv with 7 fr guideliner, 6 fr al1 catheter, 180 cm izanai wire, with unknown buddy wire in place.Midway through the procedure, the md stated that the izanai wire was stuck.The md was unable to advance or retract the izanai wire, all other products and instruments that were in place moved freely.The buddy wire was removed to try and free up the izanai wire without success.After multiple unsuccessful attempts, the md introduced a corsair pro.Additional attempts to remove the izanai wire were unsuccessful, despite the corsair pro in place.The md was ultimately able to successfully remove the izanai wire by significantly pulling with more force.A small dissection was noted, the md stated that due to multiple balloon inflations and other interventions in the same area, the root cause of the dissection could not be conclusively determined to be the izanai wire.Upon assessment of the wire once it had been removed, two distinct areas of roughness were noted on the distal portion of the wire.The patient tolerated the procedure well, and no significant harm was done, the izanai becoming stuck significantly increased the amount of fluor time.No patient was not injury, and medical or surgical intervention was not required.Patient condition was as desired.Procedure outcome was as desired.The event occurred intra-operative.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 17569165
• Report Number: 2243441-2023-00028
• Device Sequence Number: 6504701
• Product Code: DQX
• UDI-Device Identifier: 04987350734709
• UDI-Public: 04987350734709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2023
• Report Date (Section F): 08/17/2023

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 25-5211
• Device Lot Number: 221020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR AL1, UNKNOWN BUDDY WIRE; 7 FR PINNACLE DESTINATION, 7 FR GUIDELINER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/17/2023