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

Model Number	104-4470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the balloon was pre-filled in vitro, leaked air, and the operation was successfully completed after replacement.It was unknown whether the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).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.The lesion was identified as an internal carotid artery c6 segment aneurysm with a wide neck.Vessel tortuosity was reported as moderate.The cause of resistance was undetermined, and it was also unknown whether there was extensive guidewire manipulation during the procedure.The guidewire used with the balloon was the one included in the package, and during inflation, the guidewire tip was advanced approximately 3¿5 cm beyond the catheter tip.The guidewire tip was not shaped.A steady injection rate was used.The method of balloon deflation, as well as the guidewire positioning during inflation/deflation, was unknown.It was also unknown whether the catheter and guidewire were removed and inspected.No blood was reported entering the catheter lumen, and no contrast leakage was observed during inflation attempts.Additionally, no kinks on the catheter were observed during use.
Additional Manufacturer Narrative
Product analysis: as found condition: the hyperform occlusion balloon catheter and x-pedion guidewire were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Visual inspection/damage location details: upon visual inspection, no damages were found to the hyperform hub.The hyperform catheter body was found kinked at ~114.0cm from the proximal end (figure e).No damages were found to the marker bands or distal tip.No visible damages were found with the balloon subassembly.No damages were found to the x-pedion pusher or guidewire.The guidewire hydrophilic coating was found damaged.Testing/analysis: the hyperform occlusion balloon catheter was flushed, and water did not exit the distal tip.An in-house x-pedion guidewire was hydrated and then inserted into the hub, throughout the balloon catheter and became stuck at ~8.2cm from the proximal end.An in-house mandrel was inserted into the hub and became stuck at the same location.Dried saline/contrast was found at this location (figure g).Dried saline/contrast was found throughout the length of the catheter.The catheter was cut distal to the occlusion; the tip was plugged with a mandrel and the balloon was inflated with no issues.Conclusion: based on the device analysis and reported information, the customer¿s reports of ¿no/slow inflation during set up¿ and ¿catheter leak¿ was likely to have occurred.It is likely the damaged coating found on the returned guidewire caused the leak and inflation issue.However, this could not be confirmed during analysis as the hyperform balloon catheter was found occluded with dried saline/contrast.The balloon was successfully inflated when the balloon subassembly was separated from the catheter body, and the tip plugged with a mandrel.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: 22555804
• Report Number: 2029214-2025-01648
• Device Sequence Number: 9566636
• Product Code: MJN
• UDI-Device Identifier: 00763000294267
• UDI-Public: (01)00763000294267(17)260920(10)B809727
• 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): 09/29/2025

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: 09/20/2026
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B809727
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 09/03/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2024
• 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: 45 YR
• Patient Sex: Female