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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the hyperform balloon catheter was opened for use during percutaneous transluminal angioplasty (pta) performed after pipeline stent placement.During the test inflation in preparation, a minor fluid leak was observed, but considering the possibility of use, an attempt was made to use it in the procedure.However, when inflated inside the body, the balloon did not expand properly.The balloon catheter was removed and replaced with a spare of the same type that had been prepared in advance.Inflation was then possible without any issues, and the procedure was completed successfully.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
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 received.The patient was undergoing treatment for a saccular right ca aneurysm, approximately 5 mm, with normal vessel tortuosity.The device was prepared as indicated in the ifu, including inspection and hydration.The cause of the balloon leak was not determined.During the test set up, the guidewire tip was advanced approximately 3 cm out of the catheter tip, and the contrast ratio used was 50%.The balloon was inflated once outside the body and twice inside, using a medallion 1ml syringe at a steady injection rate.The location of the balloon leak was unknown, and the physician did not shape the guidewire tip.During the procedure, guidewire manipulation was normal, and an xpedion guidewire was used, with the tip advanced about 3 mm out of the catheter tip during inflation.The contrast ratio was 50% and injection was steady.Both the balloon and xpedion guidewire were hydrated as indicated in the ifu.Balloon deflation was performed using a 1ml medallion to apply negative pressure, with the guidewire advanced approximately 3 cm out of the catheter tip.It is unknown whether the catheter and guidewire were inspected for balloon performance or clot presence aftermultiple inflations, and it is also unknown if blood entered the catheter lumen or if a gentle flush was performed.Contrast was observed leaking during the inflation attempt, but no kinks were noted on the catheter during use.
Additional Manufacturer Narrative
Product analysis as found condition: the hyperform balloon catheter was returned for analysis within a shipping box, inside of a resealable plastic biohazard pouch, an opened hyperform balloon outer carton (lot- d045585), and within two resealable plastic pouches.No guidewire was returned with the balloon.Damage location details: no damage was found with the hyperform balloon catheter hub.The catheter body was found in good condition.Upon examination the distal tip was found to be damaged.The hyperform balloon was found torn from the proximal segment of the marker band subassembly and overlapping on itself at the distal segment of the balloon catheter tip.No further anomalies were observed.Testing/analysis: during testing, water was flushed through the balloon catheter without any issues.A leak was observed at the distal tip.The hyperform balloon failed to inflate during testing.No further testing was performed.Conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture during set up¿ was able to be confirmed.The hyperform balloon was returned damaged, with the balloon found to be torn off from proximal segment of the marker band subassemblies.A possible cause of ¿balloon rupture during set up¿ is but not limited to, rupture can occur when the balloon is inflated beyond the rated volume; however, the root cause was unable to be determined.Based on the device analysis and reported information, the customer¿s ¿no/slow inflation during procedure¿ was able to be confirmed, and the root cause was determined to be caused by the rupture found during preparation.The report notes that ¿during the test inflation in preparation, a minor fluid leak was observed, but considering the possibility of use, an attempt was made to use it in the procedure.¿, and ¿when inflated inside the body, the balloon did not expand properly.¿.With an attempt to use the damaged device, further damage was caused, thus unable to determine the root cause for the rupture.Both the balloon and xpedion guidewire were hydrated as indicated in the ifu.(b)(6) 2026.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: 24116038
• Report Number: 2029214-2026-00101
• Device Sequence Number: 9334826
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: D045585
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 01/19/2026; 03/20/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/10/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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