MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; MICROCATHETER

Catalog Number	CRV135-19P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During rca interventional procedure, runthrough wire used to cross rca lesion.Finecross unable to cross and "trapped" out to exchange for caravel.Caravel passed the lesion, but could not advance beyond mid-lesion.Rota wire swapped for runthrough.Caravel then backed out and became "entrapped" at the tip of the guide catheter.Parallel wire used and ptca deployed to assist with caravel removal.Catheter and wire then removed and guide changed for improved support.Rca re-wired with runthrough.Turnpike and corsair pro used to cross the lesion with no success.A second caravel was then opened and used to advance into the rca which passed the proximal and mid lesions.True lumen confirmation of wire was made and runthrough exchanged for rotawire in anticipation of rotational atherectomy.Caravel was then backed out only to be entrapped at the tip of the guide like the previous caravel micro catheter.Rotational atherectomy was performed (even with caravel tip on it distally) on the proximal section of the vessel with no success in the mid.Ptca performed on mid lesion with improved flow.Procedure halted due to time of fluoroscopy and contrast limitations.

• 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: 10359755
• Report Number: 3004718255-2020-00148
• Device Sequence Number: 3177711
• Product Code: DQY
• UDI-Device Identifier: 24547327108779
• UDI-Public: (01)24547327108779(17)221231(10)200108K0A
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2020
• Report Date (Section F): 08/03/2020

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: 12/31/2022
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 200108K10A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 90
• Date Report Sent to FDA: 08/03/2020