MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-115-08MP
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the distal tip of the navien catheter was found to be deformed.The thrombectomy was performed from the ring encapsulator. the catheter was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an intracranial aneurysm.The patient's vessel tortuosity was moderate.Additional information received reported that the patient was being treated for an aneurysm.The nurse in the catheterization lab opened it normally without any issues that resulted in the damage that was found.The damage noticed upon opening the package.There any damage or evidence of tampering to device packaging.
Additional Manufacturer Narrative
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.
Event or Problem Description
Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.
Additional Manufacturer Narrative
H3.Product analysis#: (b)(4): equipment used: vis (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the navien 072 catheter was returned for evaluation inside of a biohazard bag and a shipping box.There was no device packaging returned with the navien.Visual inspection/damage location details: the distal tip and marker band were found to be flattened.In addition, the guide catheter body was found to be kinked at 16.0cm and 45.0cm from hub.No flash or voids molded were observed in the hub.Testing/analysis: the usable length of the guide catheter was measured to be within specifications.The navien 072 catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house 0.035¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.Conclusion: based on the analysis findings, the customer complaint was confirmed as the distal tip and marker band were flattened.In addition, catheter body was also found to be kinked at several locations.However, the cause could not be determined.Catheter damage can occur during packaging or while removing the catheter from the packaging.There is no non-conformance to specifications identified that led to the reported issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the device packing were not returned; any contribution of the packaging to the reported issues could not be determined.H6.Coding updated based on analysis results.Mdr decision corrected to not reportable.The event of catheter kink/damaged did not result in a patient death or serious injury and risk management information indicates the event is not likely to cause or contribute to death or serious injury if it were to recur.No additional supplemental reports are required unless additional information received indicates a reportable event.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.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 15715270
• Report Number: 2029214-2022-01861
• Device Sequence Number: 12412569
• Product Code: DQY
• UDI-Device Identifier: 00847536017924
• UDI-Public: 00847536017924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B289115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female