MAUDE Adverse Event Report: ASAHI INTECC, INC. CARAVEL; CATHETER

Catalog Number	CRV150-19P
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was set up for a pci of the obtuse marginal.Femoral access was achieved and a 6f 3.5 ebu guide was utilized.The physician used a caravel and terumo runthrough wire.After noticing the guide wire uncoiled after crossing, he also noticed something on the wire under fluoroscopy.He then removed everything and noticed the caravel tip came off.After he confirmed nothing was left in the patient, he proceeded with procedure with same guide catheter and now changed out for sion blue, caravel, guide extension, and stent.He completed the procedure in the normal fashion with no complications.

• Brand Name: CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC, INC.; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23610491
• Report Number: 3004718255-2025-00403
• Device Sequence Number: 9444054
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)280331(10)250412K08A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/20/2025
• Report Date (Section F): 11/20/2025

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: CRV150-19P
• Device Lot Number: 250412K08A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/20/2025