MAUDE Adverse Event Report: ASAHI INTECC ASAHI CARAVEL; CATHETER

Model Number	CRV135-19P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Highly calcific posterior tibial vessel where caravel was inserted and advanced to the calcium.The tip became wedged into the calcium and as the operator attempted to advance or retract the catheter, slight torque was applied and the tip of the caravel came off on the abbott command wire.After the operator noticed that the tip of the caravel was separated from the catheter, he simply advanced a second balloon down to the tip, inflated the balloon and dragged the tip (on the command wire) back to the sheath and was safely extracted from the patient.
Event or Problem Description
Highly cacific posterior tibial vessel where caravel was inserted and advanced to the calcium.The tip became wedged into the calcium and as the operator attempted to advance or retract the catheter, slight torque was applied and the tip of the caravel came off on the abbott command wire.After the operator noticed that the tip of the caravel was separated from the catheter, he simply advanced a second balloon down to the tip, inflated the balloon and dragged the tip (on the command wire) back to the sheath and was safely extracted from the patient.

• Brand Name: ASAHI CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9513334
• Report Number: 3004718255-2019-00127
• Device Sequence Number: 16994970
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)210831(10)180924K071
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 12/13/2019
• Report Date (Section F): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRV135-19P
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180924K071
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 12/23/2019