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

Model Number FG15150-0615-1S

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline tip end could not be opened from beginning to end. the device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure were said to be normal.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the cavernous sinus segment.The max diameter was 5mm, and the neck diameter was 4mm.The patient's vessel tortuosity was moderate.The landing zone was 4mm distal and 4mm proximal.The access vessel was the femoral artery, which was 8mm in diameter.Ancillary devices include a phenom 27 microcatheter.Additional information received reported that the pipeline was placed in a straight segment of the blood vessel when it failed to open.They had attempted to retract and re-deploy, and pushed the catheter to repeatedly increase and decrease tension to try to open the device.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex device and phenom-27 micro catheter were returned for analysis within a shipping box; within their respective opened outer cartons and within their respective opened inner pouches.The already deployed pipeline flex braid was returned within the same inner pouch.Visual inspection/damage location details: the phenom-27 micro catheter was broken distal to the hub with the proximal segment not returned for analysis.The edge of the break was found stretched and jagged.The separated outer strain relief was returned separately.The phenom-27 micro catheter was found kinked at ~12.9cm, ~5.4cm, and ~0.6cm from the distal end.No damages or irregularities were found with the distal tip or marker band.Testing/analysis: the phenom-27 micro catheter total and usable length could not be measured as the device was broken and the proximal segment was not returned.The remaining micro catheter segment was measured to be ~154.4cm.Conclusion: based on the analysis findings, the customer reported devices were prepared per ifu, and vessel tortuosity as moderate.The phenom-27 micro catheter was found kinked.Possible causes are patient vessel tortuosity, guidewire/delivery system removed aggressively, catheter entrapment or user advances/retrieves device against resistance.The cause of the micro catheter break could not be determined.Event related to regulatory report #: 2029214-2022-01185.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: 15539879
• MDR Text Key: 305244382
• Report Number: 2029214-2022-01658
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• 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: OC21-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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: 61 YR
• Patient Sex: Female