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

Model Number FG11150-0615-2X

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

Healthcare professional information is not provided or reported due to country privacy laws.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a phenom catheter that had resistance and was occluded.The patient was undergoing a coil embolization to treat a carotid cavernous fistula (ccf).Vessel tortuosity was moderate.It was reported that the phenom catheter was prepared and flushed with saline per ifu.Several coils were successfully delivered by the catheter.Then, a coil was stuck during insertion.It was thought that the catheter was occluded.The physician thought the internal coating of the catheter might have peeled off and stuck causing the occlusion/resistance.The phenom catheter was removed and replaced with another manufacturer's device to complete the procedure.There was no harm or injury to the patient.

Manufacturer Narrative

H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361), in-house mandrel as found condition (condition of returned device): the phenom-17 catheter was returned for analysis within a shipping box and within a resealable biohazard pouch.The unknown coil used in the event was not returned.Visual inspection/damage location details: the phenom 17 total length was measured to be ~160.3cm and the useable length was measured to be ~152.8cm which is within specification.No damages were found with the phenom hub.The phenom 17 catheter body was found to be kinked at ~8.3cm from distal tip.No damages or irregularities were found with the distal marker/tip.Testing/analysis (including sem reports): the phenom 17 catheter was flushed, water exited from the distal tip.The phenom-17 catheter was then tested with an in-house 0.016¿ mandrel.The mandrel successfully passed through the catheter hub, lumen and exited distal tip without issue.No other anomalies were observed.Conclusion: there was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was unable to be confirmed as no issue was found during catheter resistance testing with an in-house mandrel and the root cause could not be determined.Possible causes for ¿catheter resistance¿ are continuous flush rate too low, catheter or delivery system damage or insufficient delivery system hydration.It is possible the damage (kinked) found with the catheter body contributed to the resistance.Based on the device analysis and reported information, the customer¿s report of ¿catheter occlusion¿ could not be confirmed.No occlusion was found.H6.Coding updated based on analysis results.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: 13636746
• MDR Text Key: 286579489
• Report Number: 2029214-2022-00331
• 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,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: FG11150-0615-2X
• Device Catalogue Number: FG11150-0615-2X
• Device Lot Number: OC20-022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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