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

Model Number FG11150-0615-2X

Device Problems Collapse (1099); Material Deformation (2976); Packaging Problem (3007)

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

Event Date 05/14/2023

Event Type  malfunction  

Event Description

Medtronic received report that the phenom 17 microcatheter was kinked/crushed at the distal end so it could not be inserted in the intermediate catheter.The catheter was replaced to continue the procedure.There was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a cerebral aneurysm.Vessel tortuosity was moderate.Additional information received reported that the event occurred during preparation, and the damage to catheter was observed before any prep was performed.There were no issues that resulted in the damage that was found.Additional information received reported that there was no damage or evidence of tampering with the packaging of the device.

Manufacturer Narrative

Product analysis #(b)(4): as found condition: the phenom 17 micro catheter was returned for analysis within a shipping box; within a plastic pouch; and within an opened phenom 17 outer carton and inner pouch.Visual inspection/damage location details: the catheter body was found to be kinked at 35.8cm from distal end.In addition, the catheter body was found to be broken/separated at 151.3cm from distal end.The tubing material of the broken ends exhibited jagged edges and stretching.The proximal segment of phenom catheter was not returned for analysis.Therefore, any contributing factors could not be assessed.No damages were found with the phenom-17 catheter distal marker/tip.No other anomalies were observed.Testing: the total and usable lengths of phenom 17 catheter could not be measured as the proximal segment was not returned for analysis.The phenome-17 catheter was flushed, water exited from the distal tip.An in-house mandrel was inserted through the phenome-17 catheter lumen with no issues; however, the resistance observed at the damaged locations.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damaged¿ was confirmed as the phenom 17 catheter was found to be damaged and broken.Catheter damaged can occur during packaging or while removing the catheter from the packaging.However, the root cause could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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: 17237697
• MDR Text Key: 318200463
• Report Number: 2029214-2023-00975
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• 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: 224575053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2023
• Date Device Manufactured: 06/21/2022
• 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