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

Model Number	104-4470
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis # (b)(4) equipment used: vis (m-78210).As found condition: the hyperform balloon catheter was returned for analysis within a shipping box and a plastic bio-pouch.Damage location details: the hyperform balloon catheter hub was found to be in good condition.No bends or kinks were found with the hyperform balloon catheter body.Upon microscopic inspection, a longitudinal tear/rupture in the balloon from the distal to the proximal marker band was observed.Testing/analysis: the hyperform balloon catheter was flushed, water was found leaking from the balloon.Conclusion: based on the device analysis and reported information, the customer¿s ¿rupture¿ report was confirmed.Balloon linear tear may result from rupture (inflation beyond rated volume), high inflation speed, or if the balloon is inflated after incurring mechanical damage.However, the cause 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.
Event or Problem Description
Additional information was received that the patient was undergoing treatment for a ruptured aneurysm of the left anterior communicating artery, 3.8-2.6mm.Vessel tortuosity was moderate.The device was prepared as indicated in the ifu.The cause of the balloon burst was not determined.The physician did not test the balloon prior to use.Balloon leak occurred in the middle section.The physician did not shape the guidewire tip.The balloon was inflated and deflated 2 times.The injection rate was steady.A cartridge syringe was used during inflation/deflation.
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.
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 a report that the surgeon used a balloon to assist in embolizing a ruptured aneurysm.The surgeon tested the balloon in vitro and found that it burst before reaching the pressure value.The surgeon then replaced the balloon and continued the surgery.No patient symptoms or complications were associated with this event.

• Brand Name: HYPERFORM
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20211947
• Report Number: 2029214-2024-01577
• Device Sequence Number: 7800953
• Product Code: MJN
• UDI-Device Identifier: 00763000294267
• UDI-Public: 00763000294267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101570
• 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): 11/25/2024

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: 01/16/2026
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B572822
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 09/14/2024; 10/30/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/02/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 83 KG