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	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a bot experiment was conducted, and liquid leakage occurred after the balloon was pre-inflated in vitro.No patient symptoms or complications were associated with this event.
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
Additional information was received stating that the vessel tortuosity was normal.The device was prepared as indicated in the ifu (inspection ,hydration, etc.).The procedure was completed using another product.Leakage occurred during set up.The issue was discovered during in vitro testing.The cause of the leak was not determined.The balloon performed as intended during testing.The guidewire tip was advanced 7cm out of the catheter tip during the inflation.Balloon leak was at the tip.The physician did not shape the guidewire tip.The balloon was inflated and deflated 1 time.Injection rate was slow.A 1ml syringe was used.
Additional Manufacturer Narrative
H3: product analysis as found condition: the hyperform balloon and guidewire were both returned for analysis within a shipping box and inside sealed plastic biohazard pouch.Damage location details: no damaged found on the guidewire pusher.The guidewire distal coil section was found to be damaged (bent).No damages were found with the hyperform balloon catheter hub.The catheter body was found to be bent ~42.2cm from the hub.Upon examination, the balloon was found to be in good condition.No other anomalies were observed.Testing/analysis: during testing, the hyperform balloon was hydrated.An in-house mandrel was inserted into the balloon distal tip.The balloon was inflated with a 1ml syringe and held inflation without issue.No leaks, pinholes, or ruptures were observed.The balloon worked as intended.Conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture¿ report could not be confirmed.No defect was found with the returned hyperform balloon.In addition, no leaks were able to be reproduced during testing.A possible cause for a leak could have occurred from using a damaged guidewire.The returned guidewire was found to have damage at the distal tip, which would be position at the balloons segment of the catheter.However, the root cause was determined.No damage was mentioned prior to used; therefore, all the damage occurred during the procedure.The patients vessel tortuosity was noted to be normal.The device was prepared as indicated in the ifu.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
• 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: 23593894
• Report Number: 2029214-2025-02442
• Device Sequence Number: 9924858
• Product Code: MJN
• UDI-Device Identifier: 00763000294267
• UDI-Public: (01)00763000294267(17)270306(10)D023949
• 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): 01/28/2026

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 Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: D023949
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/16/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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 Sex: Unknown