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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved progreat broke in the patient.The procedure outcome and patient condition were not reported.Additional information was received on 28jul2020.The microcatheter was inserted into patient.When manipulating, it was seen on fluoroscopy that a fragment was stuck in the patient.It was removed via a snare.The patient recovered without further complications.The procedure was completed successfully.Based on the evaluation results of the actual sample on august 5, 2020, the type of event was updated to serious injury.

• 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: 10447581
• Report Number: 2243441-2020-00049
• Device Sequence Number: 3960429
• Product Code: DQO
• UDI-Device Identifier: 04987350781215
• UDI-Public: 04987350781215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 08/25/2020

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: MC*PB2413Y
• Device Lot Number: 200121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2020
• 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: GT WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Date Report Sent to FDA: 08/25/2020