MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG15150-0615-1S

Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of a perforation during a procedure.The patient was undergoing embolization treatment of an aneurysm.Vessel tortuosity was described as normal.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the phenom felt very stiff and as a result, the wire was navigated further distally, which caused perforation.The perforation was treated by sacrificing the vessel with coils.Post-procedure, the patient was hemiplegic and could not sit up longer than 15 seconds.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9470358
• MDR Text Key: 187536794
• Report Number: 2029214-2019-01230
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00814584028981
• UDI-Public: 00814584028981
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: FG15150-0615-1S
• Device Lot Number: JA19-042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Date Device Manufactured: 01/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other