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

Model Number FG15150-0615-1S

Device Problems Break (1069); Difficult to Remove (1528); No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)

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

Event Date 03/21/2024

Event Type  malfunction  

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 Description

Medtronic received a report that the pipeline prematurely detached.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured cavernous segment of right ica with a saccular morphology.Aneurysm dimensions: max diameter 2,5 mm, neck diameter 4 mm.Landing zone: distal 3.9 mm and proximal 4.50 mm.The patient¿s vessel tortuosity was moderate.The access vessel was the right ica (5.5 mm).While deploying 3-4 mm distal segment of pipeline vantage the tip coil of delivery wire gets detached and flew into mca.Then the device was resheathed with phenom and withdrawn phenom along with device.Post procedure removed device from phenom.There was no friction or difficulty during injection.The tip coil of pipeline vantage remained in the patient¿s brain.There was force applied during removal.The catheter tip was entrapped/stuck.There was no vasospasm.There were no any surgical or medicinal interventions required.Dapt (dual antiplatelet treatment) was administered.Another pipeline was deployed but the tip coil of the delivery wire remained in patient.There were no patient symptoms or complications associated with this event.Additional information was received reporting the cause of the pipeline detachment was unknown.

Manufacturer Narrative

***this event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.*** 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 Description

Additional information received that the distal part of pusher wire broken and remained in patients body.The pushwire was broken.The catheter did not break.The catheter tip was not entrapped/stuck.No portion of the catheter remained in the patient's body; the pusher wire tip coil broken and remained in patients brain.

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 Description

Additional information received reported no intervention since the detached pusher wire reached very distally.The anatomical location of the pushwire was the distal segment of mca.

• 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: 19093191
• MDR Text Key: 340236922
• Report Number: 9612164-2024-01749
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• 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: 227525509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 10/17/2023
• 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 Sex: Male