MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; PERCUTANEOUS CATHETER

Catalog Number	CRV135-19P
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Caravel was advanced in a normal fashion over a runthrough guidewire in an n-stemi case on a 74-year-old female's rca.The vessel had a 99% calcified, tortuous lesion.Caravel was used to exchange to roto wire, and after roto, it was exchanged back to runthrough wire.While removing caravel with trapper, caravel seemed to be stuck.As they went to a balloon lesion, they noticed that 1mm of the distal tip had cracked on the wire in the rca.Md removed the wire with the entire guidewire system.The 1mm of caravel came out.There was no patient injury.Md completed the case in the normal fashion.

• Brand Name: CARAVEL
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 21289020
• Report Number: 3004718255-2025-00370
• Device Sequence Number: 9355431
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)270731(10)240815K03A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2025
• Report Date (Section F): 01/31/2025

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: 240815K03A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2025
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/31/2025