MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA

Model Number FG15150-0615-1S

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The phenom-027 micro catheter total length was measured to be ~158.6cm, the usable length was measured to be ~151.9cm and the distal single coil length was measured to be ~14.5cm which is within specification (specification: total (reference) 156.5cm, usable: 150cm ± 5cm and distal single coil: 15cm ± 2cm).No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.The phenom-027 micro catheter body was found damaged with the broken inner braid protruding out of the catheter body at ~16.1cm and ~14.6cm from the distal end.The catheter was found flattened between ~11.1cm and ~4.4cm from the distal end.The distal tip and marker band were found crushed.A 0.0260¿ mandrel was used for resistance testing.The mandrel passed through the catheter hub, catheter body and became stuck at ~148.2cm from the proximal end which is at the flattened section.No other anomalies were observed.Based on the analysis findings, the customer report of ¿catheter resistance¿ was confirmed.Resistance was found at the flattened location.The phenom-027 were confirmed to have ¿catheter damage¿.The distal catheter was found flattened and the distal tip and marker band were found crushed.Possible causes are patient vessel tortuosity, catheter entrapment, incompatible devices, user operational context if user advances or retrieves intraluminal device against resistance or customer damaged catheter during removal from packaging.The braid was found broken and exposed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the phenom outer braid was damaged in the middle section: the inner coils of the catheter were clearly visible.The doctor decided to replace the device as there was resistance felt in the middle segment while tracking the microcatheter inside the vessel.It was noted the patient's vessel tortuosity was normal.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.

• Brand Name: CATHERA
• 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: 10486291
• MDR Text Key: 206770828
• Report Number: 2029214-2020-00882
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: SE19-121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/16/2020
• Date Device Manufactured: 09/25/2019
• 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