MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM LINE EXTENSION; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4420

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/15/2024

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 information that a balloon catheter was leaking and burst.This patient had an arteriovenous fistula in the cavernous sinus segment.Using 6fguiding as proximal support, the echelon microcatheter was placed into the fistula opening.After filling the coil, the internal carotid artery was blocked with the occlusion balloon for onyx embolization.After the balloon was hydrated outside the body, it was deflated and pre-inflated.The x-pedion-10 guidewire guided the balloon to the c4 segment.The guide wire came out about 2cm from the tip of the balloon catheter.After inserting 0.25cc with a cartridge syringe, it was found that the contrast agent had leaked out.After it was withdrawn from the body, it was found that the balloon had burst.After the balloon was replaced, the operation went smoothly.  no patient symptoms or complicatiosn were reported.

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 was received.The detachable injection port was not used.The physician did test the balloon prior to use.The balloon did perform as intended during testing.The balloon leak was in the distal section.The contrast ratio was 50/50.The physician did not shape the guidewire tip.The balloon was inflated and deflated 2 times.The injection rate was steady.A 1ml syringe was used during inflation/deflation of the balloon.

• Brand Name: HYPERFORM LINE EXTENSION
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19139669
• MDR Text Key: 341420026
• Report Number: 2029214-2024-00692
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294236
• UDI-Public: 00763000294236
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104-4420
• Device Catalogue Number: 104-4420
• Device Lot Number: B542257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Date Device Manufactured: 04/03/2023
• 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: 62 YR
• Patient Sex: Female