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

Model Number	CRV135-19P
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Calcified sub total proximal lad.Plan was to rota the lesion.Was unsuccessful due to tip of microcatheter breaking off in the artery.Patient went for by pass surgery.Tip left in patient.
Event or Problem Description
Calcified sub total proximal lad.Plan was to rota the lesion.Was unsuccessful due to tip of microcatheter breaking off in the artery.Patient went for by pass surgery.Tip left in patient.
Event or Problem Description
Calcified sub total proximal lad.Plan was to rota the lesion.Was unsuccessful due to tip of microcatheter breaking off in the artery.Patient went for by pass surgery.Tip left in patient.

• Brand Name: CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9279615
• Report Number: 3004718255-2019-00122
• Device Sequence Number: 13855728
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)210831(10)180924K051
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2019
• Report Date (Section F): 11/05/2019

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: No Information
• Device Expiration Date: 08/31/2021
• Device Model Number: CRV135-19P
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180924K051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/05/2019; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/05/2019