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

Model Number 104-4770

Device Problems Burst Container or Vessel (1074); Physical Resistance/Sticking (4012)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Medtronic received information that a hyperform balloon was leaking and would not stay inflated.No patient symptoms or complications were reported.

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.

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

Additional information received clarified that the leaking was found during the procedure, but they were unsure where the leak point was.The leak was verified outside the patient.There was no extension guidewire manipulation, and a balance middle weight guidewire was used.The guidewire was said to be far enough out from the catheter tip.The guidewire tip was shaped.A 50:50 contrast ratio was used.The injection rate was slow and steady.Blood did not enter the catheter lumen, and there was no clot at the tip of the inflation holes.The leak was seen on the blank roadmap, and confirmed on the real time fluoro.There was no kink or damage observed on the catheter or guidewire during use.The physician did test the balloon prior to use, and there was difficulty getting the guidewire out of the tip.There was no friction or difficulty during inflation.A 1 cc medallion syringe was used.

Manufacturer Narrative

Product analysis #(b)(4): as found condition (condition of returned device): the hyperform balloon catheter was returned within a shipping box; within a sealed plastic pouch; within an opened hyperform balloon catheter outer carton; and within another plastic pouch.The unknown guidewire used during the event was not returned.Visual inspection/damage location details: the model and lot number for the unknown guidewire were not provided; therefore, compatibility could not be assessed.No damages or irregularities were found with the hyperform hub.No bends or kinks were found with the catheter body.Upon visual inspection, a longitudinal tear was found on balloon at distal marker band.No other anomalies were observed.Testing/analysis (including sem reports): the balloon catheter was flushed, and water exited tear on balloon and distal tip.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿balloon leak at distal gw seal¿ was confirmed as water exited tear in balloon during catheter flush.Possible cause for ¿balloon leak at distal gw seal¿ is poor fit between the guidewire and balloon inner lumen aperture.It is likely the damage (tear) to the balloon contributed to the event.The root cause for the reported event could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿guidewire resistance/stuck¿ was unable to be confirmed as the guidewire used in the event was not returned.Possible cause of ¿guidewire resistance/stuck¿ is insufficient hydration of the guidewire coating.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
• 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: 16401528
• MDR Text Key: 310144698
• Report Number: 2029214-2023-00308
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294328
• UDI-Public: 00763000294328
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091458
• 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,Followup,Followup
• Report Date: 04/10/2023

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 Expiration Date: 04/10/2024
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: B367096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/23/2023; 03/17/2023
• Supplement Dates FDA Received: 02/28/2023; 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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