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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a percutaneous coronary intervention (pci), the izanai wire was in the first diagonal, with the tip prolapsed.The physician then did a balloon angioplasty, the wire straightened out, and perforated the distal end of the first diagonal.It was observed that the patient coded.A pericardiocentesis was done, drained, an angiogram was performed, and a nester coil was placed.The patient was hypotensive 60/40.They waited; however, the patient was still bleeding, therefore they placed a second nester coil.The estimated blood loss was greater than 250cc's, 3,000cc's.The case was straightforward, non-stemi.The type of procedure was a pci and stent.Relevant tests and lab results including dates are as followed, four (4) catheterizations - one (1) on thursday (b)(6), two (2) overnight, one (1) in the evening on (b)(6).The reported event did result in patient injury and/or require medical or surgical intervention.There was a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 01nov2023: the patient was admitted to the hospital on friday (b)(6) and was discharged on thursday (b)(6).

• 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: 18170377
• Report Number: 2243441-2023-00039
• Device Sequence Number: 20769979
• Product Code: DQX
• UDI-Device Identifier: 34987350734700
• UDI-Public: 34987350734700
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/20/2023
• Report Date (Section F): 11/20/2023

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 Model Number: N/A
• Device Catalogue Number: 25-5211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/20/2023