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

Model Number	104-4470
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that a hyperform balloon ruptured.When the balloon was inflated after the approach, it was ruptured, so it was replaced with another one.The product was determined to be defective.No patient symptoms or complications were reported.
Event or Problem Description
Additional information received that when asked if the physician test the balloon prior to use, the rep stated the physician performed as procedure.The balloon performed as intended during testing.The guidewire tip was advanced out of the catheter tip 3mm to 5 mm during the inflation.The contrast ratio was a dilution rate, it's half.The physician slightly shaped the guidewire tip.The balloon got inflated and deflated zero times.The injection rate was steady.
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.

• 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: 20288382
• Report Number: 2029214-2024-01623
• Device Sequence Number: 20633060
• Product Code: MJN
• UDI-Device Identifier: 00836462004184
• UDI-Public: 00836462004184
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 11/15/2025
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B591084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 07/07/2023
• 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: Prefer Not To Disclose