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

Catalog Number	CRV150-19P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to go retrograde through an epicardial, the operator noticed a piece of the distal tip of the caravel microcatheter had sheared off.The piece of the microcatheter was noticed while removing the caravel from the anatomy.The operator attempted going retrograde through this epicardial after attempting to go antegrade through the native rca and trying to go retrograde through the septals as well as the graft.

• Brand Name: CARAVEL
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 24260132
• Report Number: 3004718255-2026-00003
• Device Sequence Number: 9766701
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)251231(10)230113K10A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/04/2026
• Report Date (Section F): 02/04/2026

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 Expiration Date: 12/31/2025
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 230113K10A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2026
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/04/2026