MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; MICROCATHETER

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Deleon describes this is a no win situation.He had made several attempts using multiple micro catheters crossing a calcified lesion with no success with any mc other than the caravel.Upon replacing the wire with a rotawire, the tip of the caravel came."pulled" off.The procedure was still performed with no harm to the patient.The tip came off with the wire and is in the packaging according to the scrub technician.

• Brand Name: CARAVEL
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11015751
• Report Number: 3004718255-2020-00190
• Device Sequence Number: 1046603
• Product Code: DQY
• UDI-Device Identifier: 24547327108779
• UDI-Public: (01)24547327108779(17)221031(10)191125K08A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 12/15/2020

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 191125K08A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2020
• 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: 12/15/2020