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

Model Number	104-4770
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was liquid leakage with a balloon, two guidewires could not exit the distal end of the balloon, one coil was stretched and replaced with a product of the same model and implanted successfully, and another coil could not be detached and was successfully implanted after replacement.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
E.Physician information was not available at the time of report.Information was requested.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 there were no issues that resulted in the damage that was found.The guidewire was able to pass the catheter hub.The guidewire tips were not shaped.
Additional Manufacturer Narrative
Product analysis: as found condition: the hyperform balloon catheter and guidewire were returned for analysis within a shipping box, a plastic bio-pouch, and a dispenser coil.The guidewire was returned within the hyperform balloon catheter.Damage location details: the guidewire was found extending out from within the hyperform catheter hub for ~43.5cm.No damages were found with the hyperform catheter hub.The hyperform catheter body was found stretched at ~4.0cm and at ~1.5cm from the distal tip.A hole/tear was found in the balloon tubing.The hyperform catheter distal tip was found damaged (indented).Testing/analysis: the guidewire could not be removed from within the hyperform balloon catheter as it was found stuck.Inflation testing could not be performed with the hyperform balloon.Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter leak¿ report could not be confirmed as inflation testing could not be performed.However, the customer¿s ¿guidewire resistance/stuck¿ report was conformed as the guidewire was found stuck.The hyperform catheter body was found stretched and the balloon was found damaged (hole/tear).It is likely that the damage to the balloon contributed to the ¿catheter leak¿ issue.The hole/tear in the balloon tubing could be due to over-inflation or sharp object contact during the procedure.The guidewire can become stuck if inserted with excessive force, leading to stretching of the catheter body.However, the cause of the guidewire resistance could not be determined.The indented distal tip suggests mechanical damage, possibly from impact.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.

• 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: 19546963
• Report Number: 2029214-2024-01086
• Device Sequence Number: 20017341
• Product Code: MJN
• UDI-Device Identifier: 00763000294328
• UDI-Public: 00763000294328
• 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,Followup,Followup
• Report Date (Section B): 09/06/2024

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: 07/23/2025
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: B601855
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 08/07/2024; 09/04/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/17/2024; 08/19/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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