MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55160-1030
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that a pipeline encountered resistance and fell off.A marksman catheter encountered resistance in the distal end.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured left ophthalmic artery aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 15 mm and neck width 5 mm.Landing zone (artery size): distal 3.2 mm and proximal 3.9 mm.The patient¿s blood flow was normal and vessel tortuosity was severe.The access vessel was the femoral artery (diameter 9 mm).It was reported that the blood vessel c1 was tortuous and the tension of the stent was too great.After deployment, the stent fell off.When the stent was retrieved into the catheter, it could not be pushed.The stent was stuck in the catheter, so the stent and catheter were withdrawn together.The second stent and catheter was very difficult to put in place.The tension was huge.When preparing to deploy the stent, it was found that it could not be pushed and the catheter was broken.The catheter and stent was immediately withdrawn.The distal end of the catheter was broken, but it did not remain in the body.Stroke onset to reperfusion time was noted as ¿3.¿ the catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with this event.Additional information was received.It was reported that they were not sure of the cause of the pipeline resistance/failure, "it may be due to vascular tortuosity and insufficient catheter support." there was no damage to the pipeline pushwire or catheter observed.There was no such thing as a stroke (originally incorrectly reported).To clarify the stent "fell off," it was reported "the stent slipped and shifted, and it got stuck during retrieving, so it could not be retrieved.".
Additional 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, drawing(s) referenced: fa-55xxx-xxxx rev.Q as found condition: the pipeline flex and marksman catheter were returned inside the inner pouch, bio-hazard bag, and shipping box.Damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The distal and proximal ends of the braid were fully opened and frayed.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.The catheter tip and marker were examined; no damages were found.However, the catheter body exhibited accordioning between 14.4 cm and 31.2 cm from the distal tip.Additionally, the catheter appeared to be separated at 29.5 cm from the distal tip, with the broken ends showing signs of stretching, necking, accordioning, and broken braids.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured and found to be within specifications.The catheter was flushed with water and found patent.The catheter was tested by running an in-house 0.026¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub without issues; however, resistance was noted at the damaged locations.Conclusion: based on the returned devices, the customer complaint was confirmed as the pipeline flex and marksman catheter were damaged.The broken ends of the catheter showed evidence of stretching, necking, accordioning, and broken braids, indicating that the catheter separated due to excessive tensile force applied to the tubing material.The observed damages, including the accordioning and separation of the catheter as well as the fraying of the braid and stretching of the hypotube, suggest that high force was exerted.This damage likely occurred when the customer attempted to advance the pipeline flex through the catheter against resistance.Possible causes for the resistance may include severe vessel tortuosity and lack of continuous flushing with heparinized saline during the delivery.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20802252
• Report Number: 9617601-2024-00353
• Device Sequence Number: 21200944
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: 00847536026278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091559
• 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,Followup
• Report Date (Section B): 01/02/2025

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 Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 227958273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 53 KG