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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the radiopaque marker on the progreat device involved broke off and migrated.The broken piece got stuck in a stenosis and the doctor was unable to retrieve it.The patient was okay.There was no patient injury/medical or surgical intervention required.The patient was in stable condition.The procedure outcome was positive.

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 14547612
• Report Number: 2243441-2022-00016
• Device Sequence Number: 5157574
• Product Code: DQO
• UDI-Device Identifier: 04987350727381
• UDI-Public: 04987350727381
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/31/2022
• Report Date (Section F): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: MC*PC2015Y
• Device Lot Number: 211027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/06/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/31/2022