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

Model Number FG11150-0615-2S

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

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

Event Date 12/12/2021

Event Type  malfunction  

Event Description

Medtronic received report that there was difficulty with flushing the phenom 17 catheter.It was reported that prior to use in the procedure, an attempt was made to flush the phenom 17 catheter with saline but the saline could not pass through.When some force was used, the saline flushed vigorously.Tip shaped was then performed.The micro guidewire was inserted and able to pass without issue.Saline flush was then done against in order to shape the tip.However, saline again could not pass through but with force applied, the saline flushed vigorously.The catheter was then replaced with a competitor's device for the procedure.As the event occurred during preparation, there was no patient involved.

Manufacturer Narrative

The phenom-17 micro catheter were returned for analysis.No damages were found with the phenom-17 micro catheter hub.No damages or irregularities were found with the catheter body.The distal tip appears to be slightly damaged from steam shaping.The phenom-17 micro catheter total length was measured to be ~158.1cm and the usable length was measured to be ~150.5cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ± 5cm).The inner diameter was measured to be 0.0165¿ at both ends.The micro catheter was flushed with water; however, water did not exit the distal end as the catheter was found occluded.An in-house mandrel was inserted into the phenom-17 micro catheter hub, through the catheter and became stuck at ~4.1cm from the proximal end.The catheter was cut; and damaged/bunched up inner liner was pushed out of the catheter.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿catheter occlusion¿ was confirmed.The cause of the resistance/occlusion is due to the damaged liner.The cause of the damage could not be determined.It is possible the damage occurred when advancing the guidewire against resistance.As the unknown guidewire used in the event was not returned for analysis, any contribution of the guidewire towards resistance could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHERA
• 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: 13744361
• MDR Text Key: 289464214
• Report Number: 2029214-2022-00402
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG11150-0615-2S
• Device Catalogue Number: FG11150-0615-2S
• Device Lot Number: 222190219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Date Device Manufactured: 05/10/2021
• 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