MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM 27 MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number FG15160-0615-1S

Device Problems Compatibility Problem (2960); Physical Resistance/Sticking (4012)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

The phenom 27 catheter was returned for analysis.No damage was found with the phenom 27 catheter hub.The catheter body was found kinked at 24.6cm and 22.7cm from the distal tip.No damage was found with the phenom 27 distal marker/tip.The phenom 27 catheter was flushed, water was seen exited under the strain relief and also from the distal tip.The strain relief was removed, the catheter body was found damaged (broken) at the distal end of the hub.An in-house 0.026¿ mandrel was inserted into the distal tip.Resistance was encountered at the kinked location but could not pass through the hub as the mandrel became stuck at the broken location.The phenom 27 catheter total length was measured to be 166.6cm, and the useable length was measured to be 160.2cm which is within specification (specification: 160cm ± 5).Based on the device analysis and reported information, the customer¿s report was confirmed.It is likely the damage (kinking) found with the returned phenom 27 catheter contributed to the event.The solitaire device used in the event was not returned; therefore, an analysis could not be performed and conformance to specification could not be assessed.Regarding the catheter break, the cause for the damage could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that they could not pass the solitaire through the catheter as there was catheter occlusion.The patient was undergoing surgery for stroke mt treatment.The patient's blood flow was not indicated and vessel tortuosity was normal.It was reported that they could not pass the solitaire through the catheter as there was catheter occlusion. the catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with the event.The device and accessory devices were prepared as indicated in the ifu.The product was replaced with a non-medtronic product.  ancillary devices include a 8f terumo guidewire, a synchro 2, and a walrus bgc red 72 solitaire 6x40.

• Brand Name: PHENOM 27 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13191673
• MDR Text Key: 290541730
• Report Number: 2029214-2022-00010
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00763000399726
• UDI-Public: 00763000399726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Device Lot Number: 221896644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG