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

Model Number 104-4112

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis of 104-4112, lotno:b232739 found no damages or irregularities with the x-pedion guidewire pusher or guidewire tip.No damages were found with the hyperglide hub, catheter body or marker bands.The distal balloon subassembly (distal to the marker band) was found damaged with what appears to be a large hole (patch missing).There was no evidence that the balloon has been previously inflated.The hyperglide occlusion balloon catheter was flushed, and water exited the distal tip.The returned guidewire was hydrated, and then inserted into the balloon catheter.The guidewire was extended out the distal tip ~3cm to test for balloon inflation.The balloon failed to inflate as water was observed to exit the damaged location.Based on the device analysis and reported information, the customer¿s reports of ¿no/slow inflation during procedure¿ was confirmed.The cause of the failure to inflate was found to be the large hole found on the balloon subassembly.The customer did not report any inflation attempts during preparation and that the balloon failed to inflate during procedure and after removal from the patient.Therefore, the cause of the damage and failure to inflate cannot be determined.It is possible the damages occurred during preparation, during insertion into the patient, or potentially during manufacturing.As manufacturing cannot be ruled out as a potential cause, a dhr review will be performed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that for a large aneurysm of the c4 segment of the internal carotid artery, 18-20mm, the physician used the occluding balloon catheter system to assist embolization.After the occluding balloon catheter system was placed in place, the balloon could not be inflated and then withdrew from the body.It also could not be inflated outside the body.  the balloon was replaced and the surgery went smoothly.No patient symptoms or further complications were reported as a result of this event.

• Brand Name: HYPERGLIDE
• Type of Device: 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: 18502796
• MDR Text Key: 333022616
• Report Number: 2029214-2024-00101
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294359
• UDI-Public: 00763000294359
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104-4112
• Device Catalogue Number: 104-4112
• Device Lot Number: B232739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male