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

Model Number	CRV135-19P
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Rca was wired successfully with a fielder fc wire and caravel catheter was placed over the fielder and successfully navigated all the way distal across the lesion.The fielder fc wire was pulled and replaced with a rotoblator floopy wire.The caravel catheter was being removed but got stuck in the proximal highly calcified 1/3rd of the rca.At the point where the catheter looked to be stuck, the physician continued to pull and noticed the tip of the caravel separated from the shaft.Several attempts were made to recover the tip but they were not successful.

• Brand Name: CARAVEL
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9668979
• Report Number: 3004718255-2020-00129
• Device Sequence Number: 14181195
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)200831(10)170912K231
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/31/2020
• Report Date (Section F): 02/04/2020

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: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: CRV135-19P
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 170912K231
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2020
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• 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: 02/04/2020