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

Model Number	104-4415
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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that for a patient with arteriovenous fistula, it was planned to use a balloon to temporarily block the arterial end.After the balloon was in place, it was filled with a card-type syringe.It was found that there was no change in the balloon.It was judged that the product might be broken.After taking it out of the body, it was found to be true.Then it was replaced with a new balloon for treatment and the operation was successfully completed.No patient symptoms or further complications were reported as a result of 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.
Event or Problem Description
Additional information received reported the balloon ruptured.During procedure, was there not extensive guidewire manipulation.Its own guidewire x-pedion was used with the balloon.During the inflation, the guidewire tip advanced 10cm out of the catheter tip.The guidewire tip was not shaped.50:50 contrast ratio was used.The injection rate was slow.Withdrew the guidewire to deflate the balloon.It was not inflated multiple times.Blood did not enter the catheter lumen.Contrast agent leakage was found.The catheter was not kinked.The balloon was tested in vitro.The balloon performed as intended.A cartridge syringe was used.
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
Product analysis: drawing(s) referenced: n/a as found condition: the hyperform occlusion balloon catheter was returned for analysis within a shipping box, within an unsealed plastic biohazard pouch and within a dispenser coil.The guidewire used in the event was not returned for analysis.Visual inspection/damage location details: upon visual inspection, no damages were found with the hyperform hub, body, marker bands, or distal tip.The hyperform balloon was found ruptured (figure d).Testing/analysis: the hyperform occlusion balloon catheter was flushed, and water did not exit the distal tip as it was occluded.An in-house guidewire was then inserted into the hub and became stuck near the hub.What appears to be dried saline/contrast was found to be at this location.The returned hyperform could not be used for in-house inflation testing due to the occlusion.Conclusion: based on the device analysis and reported information, the customer¿s reports of ¿balloon rupture during set up¿ and ¿no/slow inflation during procedure¿ were confirmed.Typically, ruptures occur when the balloon is inflated beyond the rated volume.Customer reported no extensive guidewire manipulation.The guidewire tip was advanced 10cm out of the catheter tip, the guidewire tip was not shaped, 50:50 contrast ratio was used, injection rate was slow, balloon was not inflated multiple time, blood did not enter catheter lumen, and catheter was not kinked and balloon was tested in vitro with no issues.There was no report on whether the syringe was metered.The likely cause could not be determined.As the guidewire used in the event was not returned for analysis, any contribution of the guidewire towards the rupture could not be determined.The saline/contrast found within the micro catheter likely solidified after the procedure.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 LINE EXTENSION
• 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: 22493401
• Report Number: 2029214-2025-01579
• Device Sequence Number: 4096695
• Product Code: MJN
• UDI-Device Identifier: 00763000294205
• UDI-Public: (01)00763000294205(17)260813(10)B800485
• 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: 08/13/2026
• Device Model Number: 104-4415
• Device Catalogue Number: 104-4415
• Device Lot Number: B800485
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 09/03/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 Sex: Unknown