MAUDE Adverse Event Report: ASAHI INTECC CO CARAVEL ASAHI; MICROCATHETER

Catalog Number CRV135-19P

Device Problems Partial Blockage (1065); Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Date 10/28/2019

Event Type  Injury  

Event Description

Equipment malfunction, catheter tip became dislodged in plaque of a chronic occluded vessel.Surgeon and cardiologist determined that trying to retrieve the dislodged piece would compromise distal flow so it was left alone, pt stable and will be taken to surgery later this week and equipment will be sent to risk mgmt.

• Brand Name: CARAVEL ASAHI
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC CO; 3-100 akatsuki-cho ; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9446885
• MDR Text Key: 170856965
• Report Number: 9446885
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180924K051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2019
• 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: 65 YR