MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA HEARTRAIL; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	40-6370
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a percutaneous coronary intervention, the guide catheter broke off in the body.Interventional radiology was consulted and assisted in retrieving the guide with a snare.Nothing was retained in the body.There was no harm to the patient.Medwatch mw5159442 was received on 09oct2024.Additional information was received on 10oct2024: the device did not appear to be damaged prior to use.During the procedure the device became kinked and in attempting to unkink it at the tip of the radial sheath.This was removed with a vascular snare.The procedure was completed successfully.There was no blood loss.Additional information was received on 25oct2024: the break occurred at the tip.

• Brand Name: HEARTRAIL
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20558810
• Report Number: 2243441-2024-00032
• Device Sequence Number: 3201102
• Product Code: DQO
• UDI-Device Identifier: 04987350383075
• UDI-Public: (01)04987350383075(17)270131(10)240202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 10/29/2024
• Report Date (Section F): 10/29/2024

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: 40-6370
• Device Catalogue Number: GC-U6IL350N
• Device Lot Number: 240202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• 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: SNARE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/29/2024