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

Model Number FG15150-0615-1S

Device Problems Difficult to Remove (1528); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 11/28/2022

Event Type  malfunction  

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 Description

Medtronic received a report that the physician had a successful treatment of pipeline placement.Upon retrieval of tip coil with mic rocatheter, the physician complained capturing the distal tip coil and noted severe tension/unusual friction in tracking over ptfe sleeves.The physician tried navigating into a straight segment to retrieve but was unsuccessful resulting in the full system (delivery system and phenom 27) being pulled out with no harm to the patient.Catheter stretch occurred during removal in the distal section.There was force applied during delivery or removal.The catheter tip was entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.The pipeline had resistance in the catheter in the distal section.The  catheter was flushed continuously with heparinized saline.The pipeline did not become stuck.The distal section of the catheter was accordioned.The pushwire was not damaged.The pipeline was used for an indication that is not approved (off-label), per the patient condition of ruptured, however, the patient was prepped with dapt and therapeutic.The reported devices and any accessory devices were prepared as indicated in the ifu.  the catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured left ica aneurysm with a max diameter of 2mm and a 5mm neck diameter.The landing zone was 3.2mm at the distal end and 3.6mm at the proximal end.The access vessel was the left ic with 3.5mm diameter.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered, pru level was 185.The angiographic result post procedure was a patent vessel, successful placement of flow diverter.Ancillary devices include a 6fr rist guide catheter and an aristotle 24 guide wire.

Manufacturer Narrative

H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 Description

Additional information was received that the cause of the event was not determined.

Manufacturer Narrative

H3: product analysis as found condition: the pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box, within an opened phenom 27 outer carton (222749214), and within a plastic bio-pouch.The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~47.2cm.The pipeline flex tip coil was found extending out from within the phenom 27 catheter distal tip.Damage location details: the phenom 27 catheter was found accordioned from ~6.5cm to ~8.0cm from the proximal end of the catheter hub.The phenom 27 catheter was found accordioned from ~4.5cm to ~2.0cm from the catheter distal tip.The pipeline flex pusher was found bent at the resheathing pad.The pipeline flex pusher sleeves and tip coil were found in good condition.Testing/analysis: the pipeline flex embolization device was pushed out from within the phenom 27 catheter without issue.Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance during retrieval¿ and ¿catheter accordion¿ reports were confirmed.Possible causes of the resistance include use of an incompatible catheter, catheter damage, patient vessel tortuosity, or user does not maintain continuous flush.The phenom 27 catheter is compatible for use with the pipeline flex embolization device, the patient vessel tortuosity was moderate, and the catheter was flushed continuously with heparinized saline.Therefore, incompatible catheter, patient vessel tortuosity, and user does not maintain continuous flush were ruled out as potential causes.In this event, the damage found with the phenom 27 catheter (accordioning) likely contributed to the reported resistance.Catheter damage can occur if the pipeline flex embolization device is advanced/retrieved against resistance.However, the cause for the damage could not be determined.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: 15893228
• MDR Text Key: 308069131
• Report Number: 9617601-2022-00182
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: 222749214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG