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

Model Number CRV135-19P

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

Retained microcatheter "9/" md using an asahi caravel microcatheter during pci of a chronic total occlusion.As he pulled back, the tip of the catheter dislodged mid rca and was unable to be retrieved.It was felt that the tight lesion was the cause, not a faulty product.Complication was discussed with patient.Fda safety report id# (b)(4).

• Brand Name: CARAVEL
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ASAHI INTECC HANOI CO., LTD.
• MDR Report Key: 10579565
• MDR Text Key: 208527064
• Report Number: MW5096830
• Device Sequence Number: 1
• Product Code: DQY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRV135-19P
• Device Lot Number: 191104K03A
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR