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

Catalog Number	CRV135-19P
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
While crossing the circ to the om [obtuse marginal] lesion.When dr pulled the caravel micro catheter back, he saw that the tip was not moving on xray fluoro and had broken off the caravel microcatheter.He recaptured the broken tip in the guide catheter and removed everything on the wire.While looking at the broken tip which was around 1mm in size the dr dropped it on the scrub table and it rolled off.[redacted] witnessed dr drop the piece, but they could not locate it afterwards.Dr then rewired lesion and used different brand of microcatheter to proceed with case.
Event or Problem Description
While crossing the circ to the om [obtuse marginal] lesion.When dr pulled the caravel micro catheter back, he saw that the tip was not moving on xray fluoro and had broken off the caravel microcatheter.He recaptured the broken tip in the guide catheter and removed everything on the wire.While looking at the broken tip which was around 1mm in size the dr dropped it on the scrub table and it rolled off.[redacted] witnessed dr drop the piece, but they could not locate it afterwards.Dr then rewired lesion and used different brand of microcatheter to proceed with case.

• 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: 24489766
• Report Number: 3004718255-2026-00008
• Device Sequence Number: 16121298
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)280930(10)250929K04A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/02/2026

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: 250929K04A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/25/2026
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Date Report Sent to FDA: 03/02/2026