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

Model Number 104-4470

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information reporting that during preparation, the physician found that the hyperform balloon was leaking contrast.The balloon was replaced with a competitor's device for the procedure.As the issue occurred during preparation, there was no harm to the patient.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the hyperform occlusion balloon catheter and guidewire (lot no.A765161) found no bends or kinks with the pushwire of the hyperform guidewire.A dried residue (likely saline) was found on the hyperform guidewire proximal solder region.The hyperglide guidewire distal tip was found to be bent.The hyperform guidewire distal od (outer diameter) was measured to be 0.00970¿ which is within specification (specification: 0.0103¿ max).Due to its damaged condition, the hyperform guidewire could not be used with the returned hyperform occlusion balloon catheter.The hyperform occlusion balloon catheter was then examined.Upon visual inspection, no issues or irregularities were found with the hyperform occlusion balloon catheter hub.No bends or kinks were found with the hyperform catheter body.The hyperform occlusion balloon catheter was flushed, water exited from the distal tip.In order to test for balloon inflation, a mandrel was inserted into the distal tip of the balloon for the leak test.The balloon was successfully inflated and deflated without issue.No leaks were detected.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿balloon leak at distal guidewire seal¿ could not be confirmed.It is possible that damage to the guidewire may have contributed to the reported event; however, the cause could not be determined.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d15.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

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 was received and it was reported the balloon leak was in the proximal area.The balloon was inflated and deflated two times.The injection rate was slow.A 1 mi syringe was used during inflation and deflation.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11314158
• MDR Text Key: 231403416
• Report Number: 2029214-2021-00169
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K091458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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: 11/05/2021
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: A765161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 05/05/2021; 10/01/2021
• Supplement Dates FDA Received: 05/20/2021; 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1