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

Model Number	104-4470
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	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.Initial reporter information not provided due to region's privacy laws.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 because percutaneous transluminal angioplasty (pta) was performed after pipeline (ped2-450-20) placement, the balloon was not contrast-enhanced when the hyperform was inserted and expanded in accordance with the pipeline's stent distal.There was no resistance felt during inflation, and upon removal, an attempt was made to expand the balloon outside the body, but contrast medium was leaking from the balloon.Preparation was performed as per the package insert prior to insertion, but there were no problems with the expansion and contraction.No patient symptoms or further complications were reported as a result of this event.
Event or Problem Description
Additional information received reported during the procedure there was no extensive guidewire manipulation.The guidewire was an included x-pedion10.During the inflation, the guidewire tip was advanced 4 to 6 cm out of the catheter tip.The physician did not shape the guidewire tip.Half the contrast ratio was used.The injection rate was steady.Negative pressure form a 1cc syringe was used to deflate the balloon.The guidewire was 4 to 6cm from guidewire tip during inflation/deflation.After multiple inflations, the catheter and guidewire weren't removed and inspected.Blood did not enter the catheter lumen.Contrast was not observed leaking during the inflation attempt.There were no kinks in the catheter during use.The balloon performed as intended during testing.The balloon was no inflated in the body.It was inflated 1 time out of the body.
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
H3: product analysis ¿ as found condition: the hyperform balloon catheter was returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: no damage was found with the hyperform balloon catheter hub.No bends or kinks were found with the hyperform balloon 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's distal tip, and the balloon was inflated.The balloon could not maintain inflation as it was found leaking distal to the distal marker.Upon microscopic inspection, a hole/tear in the balloon tubing was found at the location of the leak.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture¿ report could not be confirmed as the balloon was not found to be ruptured.However, the customer¿s ¿no/slow inflation¿ report was confirmed.The returned hyperform balloon was found damaged and leaking.The damage observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).In addition, it was reported that the customer confirmed successful test prior to use in the patient; therefore, damage likely occurred during 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
• 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: 22320105
• Report Number: 2029214-2025-01451
• Device Sequence Number: 21069821
• Product Code: MJN
• UDI-Device Identifier: 00836462004184
• UDI-Public: (01)00836462004184(17)251213(10)B564087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 12/13/2025
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B564087
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 08/05/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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 Sex: Male