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

Model Number	104-4470
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a hole was found in the hyperform balloon during preparation.Immediately after air was released according to the instructions for use at the time of opening, the balloon did not expand.There was no patient involvement.
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
Update b5 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 procedure was completed using a balloon from another company.The cause of the hole in the balloon was not determined, and there were no issues or evidence of tampering with the device packaging upon delivery.Balloon damage was noticed while air was being purged during setting, prior to use.It is unknown whether any preparation was performed before the damage was seen or the exact location of the balloon leak.The event occurred before the balloon was used, and the balloon was inflated and deflated once.The contrast ratio, injection rate, and type of syringe used are unknown.The balloon was flushed as indicated in the ifu, but the method used for deflation and whether contrast was observed leaking during inflation are unknown.The event occurred during setting, and no kinks were observed on the catheter during use.

• 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: 23610403
• Report Number: 2029214-2025-02459
• Device Sequence Number: 9785584
• Product Code: MJN
• UDI-Device Identifier: 00836462004184
• UDI-Public: (01)00836462004184(17)280322(10)D045585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/17/2025

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 Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: D045585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 06/16/2025
• 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