MAUDE Adverse Event Report: ASAHI INTECC ASAHI CARAVEL; CATHETER

Model Number	CRV150-19P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of caravel broke off into the patients rca and eventually drifted into a side branch leading to minimal concern.

• Brand Name: ASAHI CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9575917
• Report Number: 3004718255-2020-00128
• Device Sequence Number: 18999682
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220331(10)190403K10A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/23/2019
• Report Date (Section F): 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 190403K10A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/10/2020