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

Model Number FG15160-0615-1S

Device Problems Difficult to Advance (2920); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event reported for phenom microcatheter in lieu of analysis results.Analysis of the phenom catheter (lot no.Unknown) found that the catheter was returned in 3 segments.The pipeline flex braid was extending ~1.1 cm from separated proximal end of phenom hub.The total length of the 1st segment was measured to be ~5.0 cm.The second segment was measured to be ~2.6 cm and the 3rd segment was measured to be ~160.5 cm.The phenom catheter body was found to be flattened at ~4.7 cm for ~1.0 cm from distal tip.No damages were found with the distal tip.Based on the device analysis and reported information, the customer¿s report of ¿catheter kick back¿ was unable to be confirmed and the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline that had difficult navigation to the intended location and then failed to open and became locked up at the distal end of the catheter.A second pipeline could not be delivered because the catheter moved out of place.It was reported that the patient was undergoing a procedure for flow diversion treatment of an aneurysm.The pipelines and all accessory devices were prepared according to the instructions for use (ifu).There was difficulty navigating the phenom-27 microcatheter through the large aneurysm to the intended location but this was eventually successful when a solitaire was placed within the phenom microcatheter to take out the slack.A pipeline with shield shield (model ped2-500-16, lot: b043147) was advanced through the catheter but would not open at the distal end when delivered.More than 50% of the pipeline was deployed when the failure to open occurred.The pipeline was not positioned in a vessel bend.The device was resheathed more than 2 times; no other devices or steps were tried to open help open the pipeline.Finally the pipeline was resheathed and removed with the microcatheter.A second pipeline (model: ped-475-20, lot: a887937) was opened to be used but on advancing the pipeline, the catheter slipped out of position and access could not be regained through the aneurysm.The physician decided to stop the procedure because of long exposure for the patient.No patient injury was reported.Additional information received reported that patient was treated for a "large" aneurysm.Vessel tortuosity was moderate.The was no friction or other difficulty during the delivery of the second pipeline; the catheter was moved before the pipeline was fully advanced.The tip of the catheter was not under stress and the pipeline did not jump during deployment.Refer to manufacturer report 2029214-2021-00481 for details pertaining to the related reportable event.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12229601
• MDR Text Key: 263598320
• Report Number: 2029214-2021-00927
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2019
• 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