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

Model Number	CRV150-19P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheter tip sheared off going through the lesion.Some resistance when pulling out.Tip broke off in plaque.Snared tip out at end of case.

• 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: 9758978
• Report Number: 3004718255-2020-00134
• Device Sequence Number: 11457783
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220930(10)191003K37A
• 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): 02/14/2020
• Report Date (Section F): 02/26/2020

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 191003K37A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• 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: 02/26/2020