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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a potential coronary perforation, there was no angiographic evidence during the case.The doctor performed a percutaneous coronary intervention (pci) of the mid lad over a izanai 180 cm wire.The patient's blood pressure dropped significantly.After assessing the patient, the doctor believed the bleed to be into the pericardium.A pericardiocentesis was performed to drain the fluid.The patient became stable and was released.The doctor does not deem this to be caused by a defect of the wire.The wire did not separate or malfunction in anyway.The patient was in stable condition.The procedure outcome was a success.The event occurred intra-operative.Pericardiocentesis was required.Additional information was received on (b)(6) 2022: there was no angiographic evidence of an incident.The patient coded a few hours after the procedure.A needle was used to drain the fluid out of the pericardium.The physician stated the incident could have only been caused by a wire perforation.A boston science balloon and stent were used.

• 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: 15853750
• Report Number: 2243441-2022-00028
• Device Sequence Number: 5027481
• Product Code: DQX
• UDI-Device Identifier: 34987350734700
• UDI-Public: 34987350734700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/23/2022
• Report Date (Section F): 11/23/2022

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 25-5211
• Device Lot Number: 220829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2022
• 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: BOSTON SCI BALLOON; RUN THROUGH IZANAI; STENT
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/23/2022