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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 10/26/2022

Event Type  Injury  

Event 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
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 15853750
• MDR Text Key: 304209620
• Report Number: 2243441-2022-00028
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 34987350734700
• UDI-Public: 34987350734700
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 11/23/2022
• Distributor Facility Aware Date: 10/27/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCI BALLOON; RUN THROUGH IZANAI; STENT
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female