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

Model Number FG15160-0615-1S

Device Problem Break (1069)

Patient Problems Death (1802); Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2020

Event Type  Death  

Manufacturer Narrative

This is same event as reported in user facility/importer report number (b)(4).The device will not returned as will be retain as legal hold per hospital protocol.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a phenom 27 catheter tip "broke off in the brain" during the procedure.The patient retained a small embolized portion of the microcatheter.At the time, it was not thought the patient would experience any adverse sequela from the fragment being left in place in the small arterial vessel.The patient is now deceased as a result of the large stroke that initiated the thrombectomy procedure.The retained fragment of microcatheter did not contribute to the death of the patient.

• Brand Name: PHENOM CATHETER
• 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: 10185733
• MDR Text Key: 196145740
• Report Number: 2029214-2020-00583
• Device Sequence Number: 1
• Product Code: KRA
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: FG15160-0615-1S
• Device Lot Number: AP20-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2020
• 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): Death
• Patient Age: 66 YR
• Patient Weight: 101