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

Model Number 104-4470

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the hyperform balloon ruptured.It was reported that the hyperform balloon catheter was prepared as per the instructions for use (ifu) and inflated during preparation with no issue.During the procedure, the balloon was inflated and deflated twice, but when inflated a third time, the balloon failed to stay inflated.Once removed, it was found the balloon had ruptured.Another device was used to complete the procedure with no issues and there was no patient harm.

Manufacturer Narrative

Pupon visual inspection, no damages were found with the hyperform hub, body or distal tip.An attempt was made to flush the hyperform occlusion balloon catheter but was found occluded with what is likely dried contrast.In order to test the balloon for inflation, the catheter body was separated (cut) and a mandrel was inserted into the distal tip.An attempt was made to inflate the balloon; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker band.Upon microscopic examination, a defect (tear) in the balloon chronoprene tubing was found at the location of the leak.The guidewire was then examined.The guidewire was returned separated into two segments.The guidewire proximal segment total length was measured to be 190.0cm and the distal segment total length was measured to be 10.0cm.When compared to the product drawing, it appears all segments of the guidewire were returned.There does not appear to be any missing segments.The guidewire distal tip was found bent.No other anomalies were observed.The guidewire broken end was sent out for sem (scanning electron microscopy) analysis.Per the sem report, ¿the wire exhibits corrosion damage that obscured the original fracture features.¿ there was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ could not be confirmed as the balloon was not found to be ruptured.However, the device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).No issues were reported preparing the balloon prior to use; therefore, the damage likely occurred during the procedure.However, the root cause for the damage could not be determined.Regarding the guidewire break/separation, as the issue was not reported by the customer the root cause 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.

Event Description

2020-03-15 mpxr 712160 (hcp, rep, for): medtronic received a report that the hyperform balloon ruptured.It was reported that the hyperform balloon catheter was prepared as per the instructions for use (ifu) and inflated during preparation with no issue.During the procedure, the balloon was inflated and deflated twice, but when inflated a third time, the balloon failed to stay inflated.Once removed, it was found the balloon had ruptured.Another device was used to complete the procedure with no issues and there was no patient harm.2020-08-13 e1, e2 (for, hcp, rep): additional information received noted that the guidewire tip was advanced 7cm out of the catheter tip during the inflation, the leak was at the proximal end, 50-50 contrast ratio was used, the guidewire tip was not shaped per the ifu, the injection rate was slow, and a 1cc glass syringe was used, the patient's vessel tortuosity was minimal.

Manufacturer Narrative

Upon visual inspection, no damages were found with the hyperform hub, body or distal tip.An attempt was made to flush the hyperform occlusion balloon catheter but was found occluded with what is likely dried contrast.In order to test the balloon for inflation, the catheter body was separated (cut) and a mandrel was inserted into the distal tip.An attempt was made to inflate the balloon; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker band.Upon microscopic examination, a defect (tear) in the balloon chronoprene tubing was found at the location of the leak.The guidewire was then examined.The guidewire was returned separated into two segments.The guidewire proximal segment total length was measured to be ~190.0cm and the distal segment total length was measured to be ~10.0cm.When compared to the product drawing, it appears all segments of the guidewire were returned.There does not appear to be any missing segments.The guidewire distal tip was found bent.No other anomalies w ere observed.The guidewire broken end was sent out for sem (scanning electron microscopy) analysis.Per the sem report, ¿the wire exhibits corrosion damage that obscured the original fracture features.¿ here was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ could not be confirmed as the balloon was not found to be ruptured.However, the device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).No issues were reported preparing the balloon prior to use; therefore, the damage likely occurred during the procedure.However, the root cause for the damage could not be determined.Regarding the guidewire break/separation, as the issue was not reported by the customer the root cause 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.

• 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: 9848468
• MDR Text Key: 183937747
• Report Number: 2029214-2020-00251
• 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: 08/13/2020

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: 04/10/2022
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: A859803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 03/15/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 08/13/2020
• Supplement Dates FDA Received: 08/13/2020; 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR