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

Model Number FG15150-0630-1S

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Fistula (1862)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

The phenom as not been returned for evaluation; product analysis cannot be performed.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.Mdrs related to this event: 2029214-2019-01098 2029214-2019-01099 2029214-2019-01100.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of carotid cavernous fistula during a procedure.The patient was undergoing treatment of an unruptured aneurysm in the internal carotid artery (ica.) anatomy was reportedly very tortuous.The devices were prepared and used per the instructions for use (ifu).It was reported that during the procedure, a pipeline flex was attempted to be placed.During advancement of the pipeline flex, a large amount of force was required through the distal section of the phenom catheter.The procedure was abandoned and a carotid cavernous fistula (ccf) was noted.The ccf was coiled.The patient did not experience a neurological decline from baseline.

• 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: 9268995
• MDR Text Key: 165586254
• Report Number: 2029214-2019-01100
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00814584029001
• UDI-Public: 00814584029001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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: FG15150-0630-1S
• Device Lot Number: JA19-037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Date Device Manufactured: 01/10/2019
• 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): Required Intervention
• Patient Age: 67 YR