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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received an fda medwatch report # mw5118693.The event description states: "during pci (percutaneous coronary intervention catheter) cath interventional wire tip broke off and was left in patient's circumflex artery.Attempts to remove unsuccessful." additional information was received on (b)(6) 2023: length of wire that broke off and was left within patient anatomy was approximately 3 cm.The patient condition was stable.They attempted to snare the wire that broke off.There is no plan to remove the remaining wire fragment from the patient's body.

• 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: 17420699
• Report Number: 2243441-2023-00027
• Device Sequence Number: 12546522
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/28/2023
• Report Date (Section F): 07/28/2023

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: 25-1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2023
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/28/2023