MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5092-150

Device Problems Leak/Splash (1354); Cut In Material (2454)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

The micro catheter was returned for analysis and no issues were found with the micro catheter hub, body or distal tip, or irregularities were found with the micro catheter hub, body or distal tip upon visual inspection.The micro catheter was flushed and water was found to be leaking from both the outer and inner strain reliefs.The outer and inner strain reliefs were removed, the catheter was re-flushed, and water was found to be leaking from a hole in the catheter shaft at 5.0mm from the distal end of the hub (~11.8mm from the proximal end of the catheter shaft).Upon visual inspection of the catheter shaft, the body appears to be damaged from ~2.0mm to 11.8mm from the proximal end of catheter shaft.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter leak at hub¿ was confirmed as the returned micro catheter was found to be leaking from a hole in the catheter shaft.Although the root cause could not be determined at this time a review of the manufacturing process indicates the cause to be likely manufacturing related.A formal investigation has been initiated to address this issue.No corrective action is required at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the microcatheter was found leaking from the hub as they were attaching the saline flush bag to it during preparation.No patient injury was reported as a result of the procedure.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7404929
• MDR Text Key: 104707660
• Report Number: 2029214-2018-00255
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K093750
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5092-150
• Device Lot Number: A412079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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