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

Model Number	104-4127
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after opening the package and hydrating, the balloon was found to be leaking water.It was replaced and the surgery was completed.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
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 device was prepared as indicated in the ifu.No damage was noticed upon opening the package.Hydration was performed prior to the damage being seen.The cause of the leak was determined as leakage was found when opening the package.There was no damage or evidence of tampering to device packaging.The information is confirmed by the physician.
Additional Manufacturer Narrative
Product analysis: as found condition: the hyperglide balloon catheter and guidewire were returned for analysis within a shipping box and a plastic bio-pouch.The guidewire was returned inside the hyperglide balloon catheter.Damage location details: the guidewire extended approximately 39.6 cm from within the hyperglide catheter hub and approximately 3.0cm from within the catheter distal tip.No damage was observed on the hyperglide catheter hub.The hyperglide catheter body showed no bends or kinks.Upon visual inspection, the hyperglide balloon appeared to be in good condition.Testing/analysis: the guidewire was removed and hydrated and the hyperglide balloon catheter was flushed with water.The guidewire was reinserted through the hyperglide balloon catheter without issue, and the balloon was inflated.The balloon was found to be leaking distal to the distal marker and could not maintain inflation.Microscopic inspection revealed a tear/hole in the balloon tubing 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: HYPERGLIDE
• 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: 22042911
• Report Number: 2029214-2025-01203
• Device Sequence Number: 8880115
• Product Code: MJN
• UDI-Device Identifier: 00763000294410
• UDI-Public: (01)00763000294410(17)260430(10)B739692
• 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): 07/28/2025

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: 04/30/2026
• Device Model Number: 104-4127
• Device Catalogue Number: 104-4127
• Device Lot Number: B739692
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/02/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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 Age: 69 YR
• Patient Sex: Female