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

Model Number FG15160-0615-1S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10813874
• MDR Text Key: 215522839
• Report Number: 2029214-2020-01109
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041882
• UDI-Public: 00847536041882
• 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: 11/09/2020

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/09/2020
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1