MAUDE Adverse Event Report: ASAHI INTECC CORSAIR PRO; MICROCATHETER

Device Problems Migration or Expulsion of Device (1395); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2020

Event Type  Injury  

Event Description

Patient had a history of cad and stents.During the procedure the runthrough wire became trapped in a stent strut.Dr (b)(6) inserted the corsair in hopes of freeing the tip of the wire.When the corsair was removed the distal tip was sheared off in the distal lad.He then attempted to remove the runthrough wire again- at that time the spring coil of the wire unraveled from the distal lad, to lm into the aorta.The patient was transferred to another hospital for removal of the guidewire.

• Brand Name: CORSAIR PRO
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10268458
• MDR Text Key: 202388168
• Report Number: 3004718255-2020-00147
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020,07/08/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2020
• Distributor Facility Aware Date: 07/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization