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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/22/2020

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10447581
• MDR Text Key: 204173011
• Report Number: 2243441-2020-00049
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350781215
• UDI-Public: 04987350781215
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 08/25/2020
• Distributor Facility Aware Date: 08/05/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GT WIRE
• Patient Outcome(s): Other
• Patient Age: 51 YR