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

Model Number FG15150-0615-1S

Device Problems Break (1069); Burst Container or Vessel (1074); 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 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Refer to manufacturer report 2029214-2023-02383 for related device.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 patient was scheduled for intracranial endovascular therapy for occlusion of right ophthalmic a neurysm with flow diverter.The devices were adequately prepared and adequate measurements of the vessels were performed.The phenom 27 microcatheter was advanced to the right middle cerebral artery.The pipeline flex shield 4.00x18 was advanced.When the distal g uide of the pipeline left the sofia catheter, it was observed that it was outside the phenom microcatheter and the flow diverter was partially endoluminal released outside the microcatheter; angiographic acquisition was performed and no complications were observed and all the devices involved (pipeline, phenom 27 and sofia) were removed.An attempt was made to recover the pipeline, but it was stuck in the sofia catheter and could not be removed.It was started from the beginning, using the navien 058 catheter, a new phenom 27 microcatheter, all the devices were prepared appropriately and the pipeline flex shield 3.75x16 flow diverter was advanced, it was released without complications, covering the aneurysm neck.The procedure is performed without any complications.The patient woke up without any neurological or hemodynamic deficit.The pipeline was stuck (locked up) in the distal portion of the catheter during delivery.The catheter was flushed with heparanized saline.The physician released the load (slack) in the system in an attempt to resolve the issue, and the issue resolved.There was separation in the distal part of the microcatheter.There was no damage observed on the pushwire.The catheter was punctured (guidewire/stylet) in the distal section.There was no kink or damage on the guidewire/pushwire/stylet.There was catheter rupture (angio).The catheter was broken in the distal portion.There was catheter entrapment in the guidewire (distal)/difficult removal.There was no vasospasm.The devices are changed for new ones (distal access catheter, microcatheter and flow diverter).The pipeline was used for an approved indication.The device and any accessories were prepared 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 right internal carotid artery (ica) aneurysm with a max d iameter of 5.5mm and a 4mm neck diameter.The landing zone was 3.2mm distally and 3.6mm proximally.The access vessel was the right ica with a diameter of 3.6mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was admin istered.Dual antiplatelet therapy with clopidogrel 75mg/day and acetylsalicylic acid 100mg/day from one week prior to the intervention.Post procedure angiographic result was satisfying without any complications.Ancillary devices include a neuronmax sheath, navien 058/b335179 guide catheter, avigo/b573796.  guidewire.Refer to manufacturer report 2029214-2023-02383 for related device.

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 that it was clarified that unintended movement occurred.It was noted that it was possible that the phenom microcatheter was broken and that's why the distal guide of the pipeline came out and was partially released, without having come out in the distal part of the phenom catheter.There was a fracture inside the sofia catheter when all the systems were removed and the pipeline was tried to be recovered.There was previously unseen rupture and separation when removing all systems and trying to recover the pipeline.It was stated that it was possible that the phenom microcatheter was broken in a part where it was outside the sofia catheter, so when the pipeline was advanced, it was partially deployed without having exited the distal part of the microcatheter, remaining in the arterial vessel.

• 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: 18338047
• MDR Text Key: 330677371
• Report Number: 9612164-2023-06005
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 226898744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Date Device Manufactured: 07/10/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG