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); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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 a report that the hyperform balloon was used to perform pta after implanting the pipeline.A pta was performed after implanting the product in the area to be crimped, but the hyperform balloon was unnatural and did not inflate properly.On the screen, it was confirmed that the contrast agent was leaking from the balloon; the physician determined that it was a defect.No patient symptoms or further complications were reported as a result of this event.
Event or Problem Description
Additional information was received.Guidewire manipulation was used within the range of about 1-8 cm.The guidewire that was used with the balloon was non-medtronic.During the inflation, the guidewire tip was advanced out of the catheter tip within about 8 cm.The physician shaped the guidewire tip into a j-shape.Contrast ratio that was used was 50/50.Injection rate was steady.The balloon was flushed as indicated in the ifu.It is unknown if the guidewire hydrated for more than 30 seconds.A normal in-def with a syringe was done to deflate the balloon.It was confirmed that the catheter and guidewire was removed out of the body, but it seems that no blood clot adhesion has been confirmed.It is unknown if blood entered the catheter lumen.It seemed that it was a little difficult to guide during the catheter operation, but a kink was not confirmed.
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
Product analysis #(b)(4): equipment used: vis (m-78210).As found condition: the hyperform balloon catheter was returned for analysis within a shipping box and a plastic pouch.Damage location details: no damages were 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 hyperform balloon catheter could not be flushed, likely due to dried contrast material.To test the balloon for inflation, the hyperform catheter was dissected (cut).A mandrel was inserted into the distal tip of the balloon, and the balloon was inflated.The balloon's mid-section was found to be leaking and could not maintain inflation.Microscopic inspection revealed a tear in the balloon tubing at the location of the leak.Conclusion: based on the device analysis and reported information, the customer's "no/slow inflation" report was confirmed as the balloon was found damaged (torn) and leaking.No issues were reported preparing the balloon prior to use; therefore, the damage likely occurred during use.Damage can occur during navigation, as well as multiple inflation attempts (fatigue), overinflation, or extensive manipulation of the guidewire while the balloon is inflated.However, the cause 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: 20428917
• Report Number: 2029214-2024-01857
• Device Sequence Number: 8488044
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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: B586605
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 11/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/08/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: Unknown