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

Model Number	104-4770
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received report that during the procedure, when the doctor put the x-pedion guidewire through the hyperform balloon and attempted to inflate, the balloon did not inflate and drips came out the end of the balloon.The device was replaced with another hyperform of a different lot to complete the procedure.There was no patient injury.
Additional 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.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 or Problem Description
Additional information received reported that balloon inflation was not tested with the x-pedion wire from the same pack of hyperform.The doctor opened another package and used another x-pedion wire to inflate the balloon.There was not extensive guidewire manipulation.The physician did not shape the guidewire tip.Blood did not enter the catheter lumen.There were no kinks on the catheter during use.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an ir angiogram cerebral cutt.The patient's vessel tortuosity was normal.
Additional 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.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the x-pedion 10 guidewire was returned within a shipping box; within a sealed plastic shipping pouch; within a sealed plastic pouch; within an opened x-pedion 10 guidewire inner pouch and within a dispenser track.The hyperform balloon catheter used in the event was not returned.Visual inspection/damage location details: the total length of the x-pedion 10 guidewire was measured to be at ~ 199.9cm (reference: (b)(4)).The x-pedion 10 guidewire was found to be bent at ~ 10.9cm from the distal tip.No damages were found with the guidewire distal tip; however, the distal tip appears to have been shaped.No other anomalies were observed.Testing/analysis (including sem reports): the x-pedion 10 guidewire distal od (outer diameter) was measured at three locations and found to be within specification.The proximal od was measured to be 0.010¿, the middle od was measured to be 0.010¿ and the distal od was measured to be 0.010¿ (specification 0.0103¿ max).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿balloon leak at distal gw seal¿ and ¿no/slow inflation during procedure¿ was unable to be confirmed as the hyperform balloon catheter was not returned.The customer reported not having shaped the guidewire tip.Possible cause for ¿balloon leak at distal gw seal¿ and ¿no/slow inflation during procedure¿ is insufficient guidewire hydration.The root cause for the reported event 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.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.

• 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: 16112878
• Report Number: 2029214-2023-00034
• Device Sequence Number: 17556571
• Product Code: MJN
• UDI-Device Identifier: 00763000294328
• UDI-Public: 00763000294328
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091458
• 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): 03/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: B325013
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/21/2023; 03/15/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/24/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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