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

Model Number FG15150-0615-1S

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the distal 15mm tip of the catheter was floating freely, almost radio translucent in the m4.There was no stenosis to the vessel and the vessel was patent.It was decided to leave the tip in the m4 instead of attempting to retrieve it because it was so distal.The patient had good ante grade flow and the neuro exam was normal.The patient was heparanized post operative.There was no friction/difficulty during injection and there was no force applied during delivery or removal.There was no vasospasm and the catheter was not stuck inside the guide catheter.15mm of the catheter tip remained in the patient.The catheter was flushed as indicated in the ifu.It was unknown if the device was prepared as indicated in the ifu.The patient was undergoing treatment for a flow diversion.Ancillary devices include: benchmark sheath, 5fr sofia guide catheter, and a synchro guidewire.

Event Description

Additional information was received indicating the cause of the issue was not determined.This system was introduced in the standard triaxial system on flush lines into the benchmark catheter.During advancement, fluoroscopy demonstrated the distal tip of the microcatheter moving independently from the microwire.The system was immediately removed from the patient.Branch views demonstrated the microcatheter tip in a distal right m4 vessel.On the back table, the tri axial system was interrogated and compared to a normal phenom.027" microcatheter which allowed for them to ascertain that 15mm of the distal end of the microcatheter was missing and was the foreign body visualized on fluoroscopy.There was repeated digital subtraction angiography which showed the distal tip of the microcatheter lodged in a distal m4 on x-ray.It also demonstrated excellent anterograde flow in this m4 vessel proximal and distal to the catheter tip.

Manufacturer Narrative

H3: two phenom-27 catheters were returned for analysis within a shipping box and within a tied-up plastic pouch.Visual inspection/damage location details: (pli-10) no damages or irregularities were found with the phenom-27 hub.The distal ~15.0cm of the micro catheter was found flattened.The marker band was found separated from the micro catheter and was not returned for analysis.The distal tip was found crushed.(pli-20) no damages or irregularities were found with the phenom-27 hub.The distal ~15.2cm of the micro catheter was found flattened.The marker band was found damaged, and the distal tip was found crushed.Testing/analysis: (pli-10) the phenom-27 micro catheter total length was measured to be ~160cm and the usable length was measured to be ~153.3cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ±5cm).(pli-20) the phenom-27 micro catheter total length was measured to be ~158.5cm and the usable length was measured to be ~151.8cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ±5cm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed for the first device.The marker band was found separated from the micro catheter.Possible causes of failure are user advances/retrieves intraluminal device against resistance, vasospasm, patient vessel tortuosity, entrapment in vessel, more than 20cm of the traction was applied, fast catheter retrieval technique or user applies excessive force.Customer reported no resistance or difficulty encountered, no stenosis to vessel, no vasospasm, and devices were prepared per ifu.As the 5fr sofia guide catheter used in the event was not returned, any contribution of the guide catheter towards the marker band separation could not be determined.Both phenom-27 micro catheters were found with similar damages (damage to marker band, distal ~15cm of the catheter flattened, distal tip crushed).It is possible both devices were damaged by the same issue.Possible causes for flattening/crushing are patient vessel tortuosity, catheter entrapment, user advances/retrieves against resistance or damage during removal from packaging.There is no non-conformance to specifications found that would contribute towards the failure.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
• 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: 14265984
• MDR Text Key: 290526246
• Report Number: 2029214-2022-00746
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• 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,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 222416271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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 Age: 56 YR
• Patient Sex: Female