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

Model Number	FG15150-0615-1S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event related to regulatory report#: 2029214-2022-00814.A distal portion of the phenom 27 catheter was returned inside of a sealed bio-hazard bag and a shipping box.The proximal segment of the catheter was not returned.Visual inspection/damage location details: total length of the distal portion of the catheter was measured ~19.5cm.The catheter appeared to have been cut.No damage was found with the distal portion of the catheter.Testing/analysis: n/a.Conclusion: the distal portion of the catheter appeared to have been cut.No damage was found with the distal portion of the catheter.In addition, there was no complaint against the catheter.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.
Event or Problem Description
Medtronic received a report that the pipeline failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right carotid artery.The max diameter was 4mm, and the neck diameter was 3.6mm.The patient's vessel tortuosity was moderate.The landing zone was 4.1mm distal and 5.11mm proximal. dual antiplatelet treatment was not administered.It was reported that the pipeline never opened on the distal part and the middle part.Part of it opened, and it looked like an hourglass.The doctor performed a variety of maneuvers without success.At the moment of removing the pipeline it freed itself from the catheter.The pipeline had not been positioned in a bend, and more than 50% had been deployed when it failed to open.The pipeline had been resheathed more than 2 times.No additional steps were taken to open the device.The pipeline was removed and replaced, and the patient did not experience any injury, symptoms, extended hospitalization, or additional medical/surgical intervention.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter.Additional information received reported that the push cable was not rotated at any time, it seemed twisted in the middle part of the device, but it was not so because at one point in the procedure that part opened, but the doctor had to adjust it so that it opened in the distal segment, when it was recover it again, it never reopened in the distal or middle part.

• Brand Name: CATHERA
• Common Device Name: 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: 15214557
• Report Number: 2029214-2022-01352
• Device Sequence Number: 5566460
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151638
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 08/31/2024
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: SE21-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/11/2022
• Date Device Manufactured: 09/17/2021
• 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: 53 YR
• Patient Sex: Male