MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; CATHETER

Catalog Number	CRV150-19P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Physician started out with a corsair, and moved to caravel and tip dislodged and left in patient.No adverse events, patient is doing fine.

• Brand Name: CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi; 489-0 071; JA 489-0071
• MDR Report Key: 18061587
• Report Number: 3004718255-2023-00314
• Device Sequence Number: 7916317
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)250630(10)220712K04A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2023
• Report Date (Section F): 11/02/2023

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: 06/30/2025
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 220712K04A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 11/02/2023