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

Model Number FG15150-0615-1S

Device Problems Break (1069); Difficult to Remove (1528); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 12/23/2022

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 after the stent's microcatheter was put in place smoothly, the surgeon started to deploy the dense mesh stent.Due to the unsatisfactory landing position of the distal end, the stent was retrieved, but the stent could not be retrieved.It was also very difficult to withdraw the stent's microcatheter.Finally, after several operations, the stent's microcatheter and the dense mesh stent were withdrawn as a whole.After careful inspection in vitro, the tip of the microcatheter was obviously broken and wrapped the dense mesh stent, resulting in the failure of the overall operating system.Then a new stent's microcatheter and a dense mesh stent were selected for operation, and finally, it was successfully detached.The catheter damage was located on the distal end.The stent was stuck in the distal section of the catheter during delivery.The catheter was flushed continuously with heparanized saline.The physician released the load (slack) in the system in an attempt to resolve the issue, but the issue did not resolve.The pushwire was not damaged.The pipeline was used for an indication that is approved (on-label).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, unruptured left and right clinoid aneurysm with a max diameter of 5.4 mm and a 3.2mm neck diameter.The right side was less than 3mm.The landing zone was 3.87mm at the distal end and 4.6mm at the proximal end.It was noted the patient's vessel tortuosity was minimal.The access vessel was the femoral artery.Dapt (dual antiplatelet treatment)was administered.Due to the replacement of the catheter and the dense mesh stent, it was finally detached successfully.Angiography showed its condition was good.Ancillary devices include a navien 5f guide catheter.

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

New information was received.There was no friction or difficulty during delivery or positioning.The device did jump during deployment.The tip of the catheter was not moved during deployment. the proximal section did not open. the pipeline had not been placed in a vessel bend when it failed to open. there were no additional steps or other devices attempted to open the pipeline? (resheathing, wire/catheter, balloon, etc.).

Manufacturer Narrative

Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5), in-house 0.026in mandrel as found condition: the pipeline flex was returned stuck inside the phenom 27 catheter; within the inner pouch; inside of a sealed bio-hazard bag and a shipping box.Damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal end of the braid was found fully opened and frayed.The proximal end of the braid appeared not opened due to damaged braid.Bend was found at 25.0cm to 38.0cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be separated at 4.5cm from the distal tip.In addition, the catheter body also found to be accordioned at 3.5cm to 17.5cm from the distal tip.No other anomalies were observed.Testing/analysis: the pipeline flex was pushed out from the catheter lumen with difficulty.The catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Conclusion: based on the returned devices, the customer complaint was confirmed as the pipeline flex was stuck inside the marksman catheter.The proximal end of the braid was not opened due to damaged braid.Additionally, the catheter was found separated.From the damages seen on the catheter (accordioning/separating), braid (fraying), pushwire (bending), and hypotube (stretching); it appears there was high force used.It is possibly these damages occurred when the customer attempted to retrieve the pipeline flex through the catheter against resistance.However, the cause of resistance and failure to open could not be determined.Possible cause of failure to open includes damaged braid.The customer reported that the vessel tortuosity was minimal and continuous flush was used during delivery.Ls 2023-02-07.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.

Manufacturer Narrative

Correction: h6.Coding corrected based on previously reported analysis results summary information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 16057695
• MDR Text Key: 308539261
• Report Number: 2029214-2022-02200
• 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,Followup,Followup,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: SE21-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 02/07/2023; Not provided
• Supplement Dates FDA Received: 01/09/2023; 02/24/2023; 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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: 59 YR
• Patient Sex: Female