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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had a st-elevated myocardial infraction (stemi) patient that had a balloon/stent in the right coronary artery (rca).Upon pulling the rtns out the radiopaque tip was dislodged and had to be snared out.There were no patient complications or issues reported.The procedure was successful.Additional information was received on 26oct2021.Contrast was ran post snare to confirm there were no particles left in the patient.There was calcification and tortuosity present, they had to balloon and stent.

• 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: 12812100
• Report Number: 2243441-2021-00059
• Device Sequence Number: 20192299
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: 04987350703583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2021
• Report Date (Section F): 11/15/2021

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 25-1013
• Device Lot Number: 210407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2021
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/15/2021