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

Model Number	CRV150-19P
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the caravel catheter broke off.The catheter had been advanced past the lesion after a balloon and corsair had failed.The catheter was removed ballooning was performed.The second pass with the caravel did not advance as smoothly when dr.Halim went to remove the catheter the main body of the catheter came out but the tip was still in the artery over the wire.The wire was pulled back and the catheter remained attached to the wire.The patient remained hemodynamically stable and there were no adverse reactions.

• Brand Name: CARAVEL
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10446455
• Report Number: 3004718255-2020-00150
• Device Sequence Number: 3655821
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220930(10)191003K41A
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/29/2020
• Report Date (Section F): 08/24/2020

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: 09/30/2022
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 191003K41A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2020
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2020
• 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: 08/24/2020