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

Model Number	FG15160-0615-1S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the phenom catheter was caught on a stent, and once in the location needed, the distal tip completely came off.A snare was used to capture the tip.It was noted there was no friction during injection, no force applied, the catheter tip was no entrapped, no vasospasm, not stuck in guide catheter, and no surgical or medical intervention was required.There was no patient injury as a result of the event.The patient was undergoing surgery for an off-label venus stenting procedure.It was noted the patient's vessel tortuosity was moderate.

• Brand Name: PHENOM MICROCATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10813874
• Report Number: 2029214-2020-01109
• Device Sequence Number: 11712020
• Product Code: KRA
• UDI-Device Identifier: 00847536041882
• UDI-Public: 00847536041882
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Device Lot Number: FE20-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1