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

Model Number	104-4127
Medical Device Problem Codes	Burst Container or Vessel (1074); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a hole was detected in the hyperglide balloon while prepping.The device never went into the patient.No patient symptoms or complications were reported.
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 received reported the device was prepared as indicated in the instructions for use (ifu).The procedure was completed without the use of the hyperglide.There was no damage or evidence of tampering to device packaging.The damage to the balloon was noticed during balloon prep.The physician tested the balloon prior to use.The balloon did not perform as intended.There was a hole in the balloon.The physician did not shape the guidewire.
Additional Manufacturer Narrative
H3.Product analysis:¿ equipment used: vis (m-78210) ¿ as found condition: the hyperglide balloon catheter and guidewire were returned within a shipping box and an open hyperglide outer carton.¿ visual inspection/damage location details: no damage was found with the hyperglide balloon catheter hub.No bends or kinks were found with the hyperglide balloon catheter body.Upon visual inspection, the balloon appears to be in good condition.No bends or kinks were found with the guidewire.The guidewire appears to be in good condition.¿ testing/analysis: the hyperglide balloon catheter could not be flushed as was likely occluded with dried contrast.The balloon subassembly was dissected (cut) from the catheter body.A mandrel was inserted into the distal tip and the balloon was inflated.The balloon inflated and no leaks were detected.The guidewire outer diameter (od) was measured and found to be within specification.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture during set up¿ report could not be confirmed.No issues were encountered inflating the returned hyperglide balloon.H6.Coding updated based on analysis findings.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: 22105080
• Report Number: 2029214-2025-01258
• Device Sequence Number: 17981086
• Product Code: MJN
• UDI-Device Identifier: 00763000294410
• UDI-Public: (01)00763000294410(17)260621(10)B789712
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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: 06/21/2026
• Device Model Number: 104-4127
• Device Catalogue Number: 104-4127
• Device Lot Number: B789712
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 08/18/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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