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

Model Number	104-4420
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	02/07/2025
Type of Reportable Event	Malfunction
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
Medtronic received a report that after opening the package and taking out the balloon, a inflation test was performed in vitro and it was found that the balloon was leaking water and could not be inflated.No patient symptoms or further complications were reported as a result of this event.
Event or Problem Description
Additional information received reported a self-contained guidewire was used.The guidewire was advanced 1 cm out of the catheter tip.The guidewire tip was not shaped.The injection rate was steady.Used cartridge syringe to aspirate out and deflate balloon.The guidewire was 7mm from the catheter tip during inflation/deflation.After multiple inflations, the catheter and guidewire eas not removed or inspected.Blood did not enter the catheter lumen.Contrast was observed leaking during the inflation attempt.The catheter was not kinked.The physician tested the balloon prior to use.The balloon did not perform as intended during testing.The balloon leak was at the tip, contrast ration was 50/50.The balloon gat inflated and deflated 3 times.
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: as found condition: the hyperform balloon catheter was returned for analysis within a shipping box, a plastic bio-pouch, and a dispenser coil.Damage location details: no damages were found with the hyperform balloon catheter hub.What appears to be dried contrast was found with the catheter hub.No bends or kinks were found with the catheter body.Testing/analysis: 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 distal tip, and the balloon was inflated.The balloon could not maintain inflation as it was found leaking at the distal tip.Upon microscopic inspection, a tear in the balloon tubing was found at the location of the leak.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: 21344643
• Report Number: 2029214-2025-00344
• Device Sequence Number: 21101881
• Product Code: MJN
• UDI-Device Identifier: 00763000294236
• UDI-Public: 00763000294236
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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: 10/02/2025
• Device Model Number: 104-4420
• Device Catalogue Number: 104-4420
• Device Lot Number: B532917
• 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: 02/08/2025
• Supplement Date Received by Manufacturer: 02/12/2025; 04/02/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/27/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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: 69 YR
• Patient Sex: Female