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

Model Number CRV150-19P

Device Problems Break (1069); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

The tip of the caravel catheter broke off.The catheter had been advanced past the lesion after a balloon and corsair had failed.The catheter was removed ballooning was performed.The second pass with the caravel did not advance as smoothly when dr.Halim went to remove the catheter the main body of the catheter came out but the tip was still in the artery over the wire.The wire was pulled back and the catheter remained attached to the wire.The patient remained hemodynamically stable and there were no adverse reactions.

• 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: 10446455
• MDR Text Key: 204282965
• Report Number: 3004718255-2020-00150
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220930(10)191003K41A
• 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: 08/24/2020,07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 191003K41A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2020
• Distributor Facility Aware Date: 07/29/2020
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1