MAUDE Adverse Event Report: MEDTRONIC MEXICO CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG11150-0615-2X

Device Problems Material Deformation (2976); Packaging Problem (3007)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the microcatheter was kinked and damaged when just opened.Additionally, the coil couldn't be pushed out of the protective sheath.The device and any accessories 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 cavernous sinus segment aneurysm with a max diameter of 1.7mm and a 1.2mm neck diameter.The access vessel was the femoral artery with a diameter of 8.9mm.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information received that the catheter damage was noticed immediately after removing the device from the box.There was no damage or evidence of tampering to device packaging.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

Manufacturer Narrative

H3: product analysis of fg11150-0615-2x, lotno:224415696 found no damages with the phenom-17 catheter hub.The phenom-17 catheter body was kinked at ~7.3cm and ~41.8cm from the proximal end.The distal tip outer layer was delaminated from the marker band and the inner liner.The phenom-17 micro catheter total length was ~158.8cm and the useable length was ~151.3cm which is within specification (specification: total (ref) = 156.5cm; usable = 150cm ± 5cm).Based on the device analysis and reported information, the customer¿s report of ¿catheter kinked/damage¿ was confirmed.It is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.However, the root cause could not be determined.The distal catheter was found delaminated.No other damages could be found along with the delamination; therefore, it is not likely due to advancing against resistance or use related.As the inner pouch and dispenser coil were not returned for analysis, any contribution of the packaging towards the damages could not be assessed.There was an indication that the event was related to a potential manufacturing issue, so a device history record review will be performed.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): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18761489
• MDR Text Key: 336420780
• Report Number: 9612164-2024-00906
• Device Sequence Number: 1
• Product Code: KRA
• 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: 02/22/2024

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: FG11150-0615-2X
• Device Catalogue Number: FG11150-0615-2X
• Device Lot Number: 224415696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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 Sex: Male