MAUDE Adverse Event Report: ASAHI INTECC ASAHI CARAVEL; CATHETER

Model Number	CRV150-19P
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Microcatheter broke off inside a patient's rca and embolized down the artery piece of catheter left in patient due to r/b of retrieval.

• 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: 9356091
• Report Number: 3004718255-2019-00125
• Device Sequence Number: 479594
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220331(10)190403K10A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2019
• Report Date (Section F): 11/21/2019

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 Expiration Date: 03/31/2022
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 190403K10A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1