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

Model Number	104-4127
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
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 during a pipeline surgery, a balloon was used for post-processing.After the balloon was in place, a syringe was used to expand it normally.After expansion, it was found that the balloon was leaking and damaged, so the balloon was replaced.There were no patient symptoms or complications associated with this event.
Event or Problem Description
Additional information was received that the cause of the balloon leak/damage was the balloon rupture during inflation.The physician did not test the balloon prior to use.The guide wire came out 15mm from the tip of the balloon during the inflation.The physician did not shape the guidewire tip.The balloon was inflated and deflated 2 times.The injection rate was steady.It was noted that an ordinary 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
H3: product analysis of 104-4127, lotno:b474510 ¿ as found condition: the hyperglide balloon catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an opened hyperglide inner pouch (b474510) ¿ damage location details: no damages were found with the hyperglide balloon catheter hub.The hyperglide balloon catheter body was found stretched at ~2.5cm from the distal tip.Upon visual inspection, the hyperglide balloon appears to be in good condition.There does not appear to be any ruptures of the balloon.The hyperglide balloon catheter distal tip appears to be in good condition.¿ testing/analysis: the hyperglide balloon catheter was flushed, water exited from the damaged (stretched) location and distal tip.Due to its damaged condition, the balloon could not be tested for inflation.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿balloon rupture during procedure¿ report could not be confirmed as no ruptures were found with the balloon.The hyperglide balloon catheter body was found stretched and leaking, likely contributing to the reported event.Catheter damage can occur if the catheter/guidewire is advanced/retrieved against resistance.However, the cause of the catheter 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: 19325274
• Report Number: 2029214-2024-00923
• Device Sequence Number: 2569734
• Product Code: MJN
• UDI-Device Identifier: 00763000294410
• UDI-Public: 00763000294410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/15/2024

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: 08/22/2025
• Device Model Number: 104-4127
• Device Catalogue Number: 104-4127
• Device Lot Number: B474510
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 06/16/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: Female
• Patient Weight: 50 KG