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

Model Number 104-4112

Device Problem Leak/Splash (1354)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

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 the patient had an aneurysm in the posterior communicating segment of the left internal carotid artery.The surgical plan was balloon-assisted coil embolization.Before the surgery, the inner cavity of the balloon was flushed with contrast medium saline in a 10ml syringe.When it was deflated, it was found that the balloon was leaking water, so it was replaced with a new balloon.No patient symptoms or further complications were reported as a result of this event.

Event Description

Additional information was received that the cause of the leak was unknown.There was no obvious damage or evidence of tampering to device packaging.

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis: as found condition: the hyperglide occlusion balloon catheter was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; and within an opened x-pedion inner pouch.The opened hyperglide inner pouch was also returned.The x-pedion guidewire used in the event was not returned for analysis.Visual inspection/damage location details: upon visual inspection, no damages were found with the hyperglide hub.A rupture was found on the hyperglide catheter body at ~16.7cm from the distal end.The catheter near the rupture was found stretched.No visible damages were found with the balloon subassembly, marker bands or distal tip.Testing/analysis: the hyperglide occlusion balloon catheter was flushed, and water did not exit the distal tip.An in-house guidewire was then inserted into the hub, through the catheter and became stuck at ~112.2cm from the proximal end (proximal to rupture).The catheter was cut, and dried contrast/saline was found occluding the stuck location.The contrast dissolved when water was applied to the occlusion.Conclusion: based on the device analysis and reported information, the customer¿s reports of ¿catheter leak¿ was confirmed.The leak is likely to be caused by the rupture found on the catheter body.As the edges of the rupture was found stretched, the likely cause is over pressurization.Possible causes of failure include injection while the distal portion of catheter is kinked/prolapsed/occluded, wrong type of syringe to use with saline/contrast or use of power injector.The hyperglide balloon catheter was found occluded with dried contrast/saline.It is not known when the contrast had solidified.As the guidewire used in the event was not returned for analysis, any contribution of the guidewire towards the catheter leak/rupture could not be determined.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.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.

• 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: 17290604
• MDR Text Key: 319072804
• Report Number: 2029214-2023-01064
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Model Number: 104-4112
• Device Catalogue Number: 104-4112
• Device Lot Number: B256001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 08/24/2023
• Supplement Dates FDA Received: 08/16/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG