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

Model Number	104-4470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
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.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 when using the hyperform balloon, air leakage was found when venting outside the body.No patient symptoms or further complications were reported as a result of this event.Additional information received that when the balloon was deflated outside the body, contrast agent was found to have leaked out.There was no guidewire operations.An xpedion guidewire was used with the balloon.During the inflation, the guidewire tip was advanced out of the catheter tip about 1 cm.The physician did shape the guidewire tip.Contrast agent and saline 1:1 ratio.The injection rate was steady.The method used to deflate the balloon was withdrawal with a syringe.There were not multiple inflations, and contrast agent leakage was found during the first inflation.Blood did not enter the catheter lumen as the balloon did not enter the patient.Contrast was observed leaking during the inflation attempt.There were no kinks on the catheter during use.
Additional Manufacturer Narrative
H3: the hyperform balloon catheter and guidewire were returned for analysis.No damages were found with the hyperform catheter hub.The hyperform balloon catheter body was found stretched at ~1.4cm from the distal tip.Upon visual inspection, the balloon appears to be in good condition.The guidewire distal tip was found bent.The characteristic of the bent guidewire distal tip is consistent with tip shaping.An in-house mandrel was inserted into the balloon catheter distal tip to test the balloon for inflation.The balloon was found leaking at the proximal marker.Upon inspection, a hole/rupture was found in the balloon tubing at the location of the leak.Based on the device analysis and reported information, the customer¿s report was confirmed as the balloon was found damaged and leaking.However, the cause of the balloon damage could not be determined 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: 19570525
• Report Number: 2029214-2024-01102
• Device Sequence Number: 17677477
• Product Code: MJN
• UDI-Device Identifier: 00763000294267
• UDI-Public: 00763000294267
• 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
• Report Date (Section B): 08/01/2024

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: 01/25/2026
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B571437
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: 12 MO
• Patient Sex: Male