MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; MICROCATHETER

Catalog Number	CRV135-19P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Caravel's tip broke off in the patient's cx when trying to withdraw the caravel over the grand slam.

• Brand Name: CARAVEL
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 48900 71; JA 4890071
• MDR Report Key: 10451682
• Report Number: 3004718255-2020-00152
• Device Sequence Number: 2687695
• Product Code: DQY
• UDI-Device Identifier: 24547327108779
• UDI-Public: (01)24547327108779(17)230331(10)200411K10A
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 200411K10A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2020
• 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
• Patient Age: 81 YR
• Date Report Sent to FDA: 08/25/2020