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

Model Number N/A

Device Problems Break (1069); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/06/2022

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 14547612
• MDR Text Key: 292972006
• Report Number: 2243441-2022-00016
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350727381
• UDI-Public: 04987350727381
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/31/2022
• Distributor Facility Aware Date: 05/06/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other