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

Model Number	104-4420
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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 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inserting 0.25cc with a cartridge syringe, it was found that the contrast agent had leaked out.After it was withdrawn from the body, it was found that the balloon had burst.After the balloon was replaced, the operation went smoothly.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.
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
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.
Additional Manufacturer Narrative
Product analysis #(b)(4):¿ equipment used: vis (m-78210) ¿ as found condition: the hyperform occlusion balloon catheter was returned for analysis within a shipping box, a plastic pouch, and an opened hyperform inner pouch (b542257).¿ damage location details: no damages were found with the hyperform catheter hub.No bends or kinks were found with the catheter body.The hyperform balloon was found torn/ruptured.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture¿ report was confirmed as the returned hyperform balloon was found torn/ruptured.Balloon rupture can occur due to over-inflation, high inflation speeds, not using a cadence syringe, or inflation when the balloon is not well visualized.However, the cause of the balloon rupture could not be determined.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: HYPERFORM LINE EXTENSION
• Common Device Name: 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
• Report Number: 2029214-2024-00692
• Device Sequence Number: 9384128
• Product Code: MJN
• UDI-Device Identifier: 00763000294236
• UDI-Public: 00763000294236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2026
• Device Model Number: 104-4420
• Device Catalogue Number: 104-4420
• Device Lot Number: B542257
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 04/19/2024; 05/30/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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: 62 YR
• Patient Sex: Female