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

Model Number CRV150-19P

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  Injury  

Event 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
• Type of Device: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9758978
• MDR Text Key: 181578476
• Report Number: 3004718255-2020-00134
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220930(10)191003K37A
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2020,02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2020
• Distributor Facility Aware Date: 02/14/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention