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

Model Number FG11150-0615-2X

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

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

Medtronic received information that the saline could not flow through when the phenom catheter was flushed.On top of that, the wire too could not pass through.The devices were prepared as indicated in the package insert.The catheter was flushed as indicated in the instructions for use (ifu).The patient was undergoing a cerebral aneurysm embolization.The access vessel was the internal carotid artery (ica) with a diameter of 4mm.Vessel tortuosity had no anomalies.No symptoms were reported.Additional information was received indicating the guidewire was able to pass the catheter hub.There was no damage found to the catheter hub.The guidewire was a non-medtronic product.

Manufacturer Narrative

Product analysis #: 705010735: equipment used: video inspection system (m-81805), ruler (m-83360), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5), in-house 0.0160¿ mandrel drawing(s) referenced: dwgsfg11xxx-yyyy-zz rev.F as found condition: the phenom-17 micro catheter were returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The unknown non-medtronic guidewire used in the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the phenom-17 micro catheter hub.The phenom-17 micro catheter was found kinked at ~0.4cm from the distal end.The distal tip and marker band was found intact.Testing/analysis: the phenom-17 micro catheter total length was measured to be ~158.5cm and the usable length was measured to be ~151.0cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ± 5cm).The phenom-17 micro catheter inner diameter was measured to be 0.017¿at both ends, which is within specification.The micro catheter was flushed with water; however, water did not exit the distal end as the catheter was found occluded.An in-house 0.0160¿ mandrel was inserted into the phenom-17 micro catheter hub, through the catheter and became stuck at ~4.3cm from the proximal end.The catheter was cut, and damaged inner liner was found to occlude the stuck location.The mandrel was inserted into the distal end of the micro catheter and resistance was encountered at the kinked location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter occlusion¿ and ¿catheter resistance¿ were confirmed.The cause of the resistance and occlusion was found to be the damaged inner liner.The cause of the damage could not be determined.Possible causes for damage are incompatible guidewire, advancing the guidewire against resistance, or device not hydrated prior to use.As the unknown guidewire used in the event was not returned for analysis, any contribution of the guidewire towards resistance and catheter occlusion could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The distal micro catheter was found kinked, which potentially could contribute towards resistance and damage.Possible causes for catheter kink are patient vessel tortuosity, guidewire/delivery system removed aggressively, incompatible guidewire, catheter entrapment or user advances device against resistance.Ngod10 2022-07-10 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15152893
• MDR Text Key: 304897051
• Report Number: 2029214-2022-01292
• 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: Other
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG11150-0615-2X
• Device Catalogue Number: FG11150-0615-2X
• Device Lot Number: 223242579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Male