MAUDE Adverse Event Report: ASAHI INTECC CO LTD CARAVEL; CATHETER

Catalog Number	CRV135-19P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) had the tip of a caravel come off in a patient.Dr.(b)(6) removed the tip with a snare.

• Brand Name: CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 24279071
• Report Number: 3004718255-2026-00005
• Device Sequence Number: 18623685
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)280430(10)250428K16A
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/06/2026
• Report Date (Section F): 02/06/2026

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 Catalogue Number: CRV135-19P
• Device Lot Number: 250428K16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2026
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 02/06/2026