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

Model Number	104-4715
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	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that in the operation of arteriovenous fistula, the glue was injected, and the balloon assisted to block the fistula.When the balloon was opened, it did not enter the human body.When it was pre-inflated, it was found to be broken, and a new balloon was replaced to continue the operation.The operation ended smoothly and the patient was not harmed.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.
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 cause of the balloon being broken was not determined.The physician tested the balloon prior to use.The balloon did not perform as intended during testing.The physician shaped the guidewire tip.The injection rate was steady.
Additional Manufacturer Narrative
H3: the hyperform balloon catheter was returned for analysis.No damage was found with the hyperform balloon catheter hub.No bends or kinks were found with the hyperform balloon catheter body.The hyperform balloon catheter could not be flushed as it is likely occluded with dried contrast.Therefore, the balloon subassembly was dissected (cut).A mandrel was inserted into the balloon's distal tip, and the balloon was inflated.The balloon could not maintain inflation as it was found leaking.Upon microscopic inspection, a tear in the balloon tubing was found at the location of the leak.Based on the device analysis and reported information, the customer¿s report was confirmed as the balloon was found damaged (torn) and leaking.However, the cause of the balloon damage could not be determined.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: 21562386
• Report Number: 2029214-2025-00608
• Device Sequence Number: 9170468
• Product Code: MJN
• UDI-Device Identifier: 00763000294298
• UDI-Public: 00763000294298
• 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): 05/12/2025

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: 06/22/2026
• Device Model Number: 104-4715
• Device Catalogue Number: 104-4715
• Device Lot Number: B794924
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 04/29/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/04/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: Female