MAUDE Adverse Event Report: MEDTRONIC MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

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

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the catheter was kinked at the distal end.The patient was undergoing surgery for an intracranial aneurysm.It was noted the patient's vessel tortuosity was minimal.It was reported that a standard operation was performed and slowly delivered.As the ped was delivered through the y valve, they removed the protective sheath and continued to push it and the resistance was very large.When the ped's tip was deployed, it was difficult to open the middle section.After it was successfully deployed, the rivet stuck to the wall well.The marksmen was pushed to go upper to retrieve the ped guidewire and the recovery was difficult.The adjustments were repeated however they were unsuccessful, the forward push for recovery was also unsuccessful.The navien could not pass the proximal end of the ped and only the guidewire could be pushed and it was not retrieved in the marksman to withdraw.During this process, the protective sheath of the guidewire tip was hooked with the deployed ped.After the advancement, the stent was withdrawn with the stent hooked.After, the withdrawal was adjusted until the ped fell into the aneurysm.It was observed in vitro that a soft section of the tip of the catheter was in an accordion.The devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.

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

Additional information was received.The pipeline was not placed in a vessel bend when it failed to open, it was in the straight segment of the middle cerebral artery.There were no additional steps or other devices attempted to open the pipeline.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC; irvine
• Manufacturer (Section G): MEDTRONIC; irvine
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12734089
• MDR Text Key: 284473436
• Report Number: 2029214-2021-01375
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: 00847536026261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 222079168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female