MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERGLIDE 5.0 X 20 MM BALLOON; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4520

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

The hyperglide balloon has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that balloon ruptured during the procedure.It was reported the patient underwent surgery with medtronic flow diverter implantation.After the flow diverter was released, the balloon was used for post-treatment.The balloon was filled and expanded normally for the first time.The balloon ruptured when the second time was not injected to the burst pressure.There were not any patient symptoms or complications associated with this event.No patient injury was reported.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, upon visual inspection, no damages or irregularities were found with the hyperglide occlusion balloon catheter hub.No bends or kinks were found with the hyperglide catheter body or distal tip.The guidewire distal tip was found to be bent.The characteristic of the bent guidewire distal tip is consistent with shaping.However, the physician stated that did not shaped the guidewire tip.Therefore, the cause for the bent guidewire distal tip could not be determined.An attempt was made to inflate the balloon in returned condition; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker.Upon microscopic examination, a defect (hole) in the chronoprene tubing was found at the location of the leak.No ¿ruptures¿ were found with the balloon.No other anomalies were observed.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 (hole) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).In this event use context likely contributed to the damage.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: HYPERGLIDE 5.0 X 20 MM BALLOON
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8842889
• MDR Text Key: 152786378
• Report Number: 2029214-2019-00795
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K090728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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: 02/05/2022
• Device Model Number: 104-4520
• Device Lot Number: A807471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR