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	03/01/2024
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.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 aneurysm embolization was performed.After the balloon was in place, it was inflated.Leakage of the balloon was found, another balloon was replaced, filled smoothly, and the operation was completed no patient symptoms or further complications were reported as a result of this event.Additional information received that the balloon did not inflate.The leak was observed inside the body.It was clarified that liquid was leaking.
Additional Manufacturer Narrative
H3: product analysis of 104-4770, lotno:b439083 damage location details: no damage was found with the hyperform catheter hub.No bends or kinks were found with the hyperform catheter body.Upon visual inspection, the balloon appears to be in good condition.Upon microscopic examination, a defect (tear) in the balloon choroprene tubing was found at the location of the leak.No other anomalies were observed.Testing/analysis: the hyperform occlusion balloon catheter was flushed and water was found to be leaking at the balloon choroprene tubing.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿balloon leak at distal gw seal¿ was prior to use; therefore, the damage likely occurred during use.The damage observed is consistent with mechanical or navigation related damage.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.
Event or Problem Description
Additional information was received that the liquid was saline.The catheter leak was observed in the distal section.The device was removed and replaced to continue the surgery.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19020224
• Report Number: 2029214-2024-00555
• Device Sequence Number: 8032704
• 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
• Report Date (Section B): 04/29/2024

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: 08/24/2024
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: B439083
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: Unknown