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

Model Number	104-4112
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that a hypergluide balloon was leaking.The balloon leaked liquid.After replacing it, it was used smoothly.No patient symptoms or complications were reported.The device prepared as indicated in the ifu.The cause of the balloon leak was not determined.The matching guidewire was used with the balloon.The guidewire tip was unshaped.The guidewire was about 3cm from the catheter tip during inflation/deflation.The physician did test the balloon prior to use.The balloon did perform as intended during testing.The contrast ratio was 50/50.The injection rate was steady.A cartridge syringe was used during inflation/deflation of the balloon.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the hyperglide balloon catheter and guidewire were returned for analysis within a shipping box and a plastic bio-pouch.The guidewire was returned within hyperglide balloon.¿ damage location details: the guidewire was extending out from hyperglide balloon hub.No damages were found with the hyperglide ca theter hub.The hyperglide balloon catheter body was found accordioned from ~18.0cm to ~13.0cm from distal end.No damages or irregularities were found with the hyperglide balloon/distal tip.The guidewire was found bent at ~16.5cm from proximal end.No damage was found with distal guidewire.No other anomalies were observed.¿ testing/analysis: the hyperglide balloon catheter was flushed, water exited from the distal tip.The guidewire was repositioned, and the balloon was inflated.The balloon could not maintain inflation as it was found leaking at the distal tip.Upon microscopic inspection, a hole/tear was found at the location of the leak.The balloon was found leaking at ~1.4cm from distal tip.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿balloon leak¿ report was confirmed as the balloon was found leaking.As no issues were reported during the balloon preparation, damage likely occurred during use.However, the cause of the 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: HYPERGLIDE
• 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: 20051214
• Report Number: 2029214-2024-01465
• Device Sequence Number: 20862421
• Product Code: MJN
• UDI-Device Identifier: 00763000294359
• UDI-Public: 00763000294359
• 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
• Report Date (Section B): 08/22/2024

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: 02/09/2026
• Device Model Number: 104-4112
• Device Catalogue Number: 104-4112
• Device Lot Number: B606860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Date Device Manufactured: 08/07/2023
• 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