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

Model Number	104-4127
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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
It was reported that during a neurovascular procedure involving the hyperglide 4.0 x 20 mm 4 mm tip system, the occlusion balloon ruptured before reaching its maximum volume.The balloon, initially inflated with a 1:1 contrast agent and anticoagulant water mixture, suddenly deflated when inflated to the standard capacity with a cartridge syringe.Attempts to reinflate the balloon with the same mixture were unsuccessful, and it was suspected to have burst.Upon removal from the body, the burst was confirmed.The procedure involved addressing a left internal carotid cavernous fistula, with bilateral puncture performed.The left side used an 8f 95cm guiding catheter, and the right side used a 6f 105cm johnson & johnson envoy da.Two echelon10s were used, one for embolization coils and the other for glue injection.After the initial balloon failure, a replacement hyperglide-4-20 balloon of the same model and size was used, which inflated successfully and effectively sealed the cavernous sinus fistula.The procedure continued with the use of echelon 10 coils, axium-22-50-3d coils, bridge coils, and onyx injections, with angiographyconfirming the complete blockage of the fistula.The blood flow in the internal carotid artery returned to normal, and the operation was successfully completed.No patient symptoms or complications were reported.
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 in vitro pre-filling and balloon testing showed no abnormalities and everything was done ac cording to standard operations.The in vitro test was in line with expectations, no abnormalities, everything was normal.The guidewire tip was advanced out of the catheter tip about 4 cm.Under dsa, it was found that the contrast agent suddenly leaked out of the balloon, and the balloon no longer showed image.At the same time, it did not have the effect of blocking the blood vessels (confirmed by angiography), so it had to be withdrawn outside the body.The specific air leakage point of the balloon could not be observed with the naked eye.The contrast ratio was 50%, 1/1 heparin and saline.There was no shaping of the guidewire.The balloon was inflated and deflated 1 time.The injection rate was slow.A cartidge syringe was used.
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: ¿ as found condition: the hyperglide balloon catheter and guidewire were 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.The guidewire was found bent at ~1.3cm from its distal tip.¿ testing/analysis: the hyperglide balloon catheter was flushed, water exited from the distal tip.The guidewire was hydrated and inserted through the hyperglide balloon catheter, and the balloon was inflated.The distal end of the balloon 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.No ¿ruptures¿ were found with the balloon.¿ conclusion: based on the device analysis and reported information, the customer¿s 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: 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: 20849230
• Report Number: 2029214-2024-02241
• Device Sequence Number: 3758307
• Product Code: MJN
• UDI-Device Identifier: 00763000294410
• UDI-Public: 00763000294410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021066
• 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): 03/10/2025

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: 04/11/2026
• Device Model Number: 104-4127
• Device Catalogue Number: 104-4127
• Device Lot Number: B732588
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/11/2025; 02/11/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/11/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 73 YR
• Patient Sex: Female