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

Model Number 104-4310

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

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

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported event has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has ben sent out to the customer.Once the device has been received and the investigation has been completed, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic balloon occlusion system failed to inflate.Prior to the event, the balloon was prepared as indicated in the instructions for use (ifu) and then placed inside the patient.Once inside, the reported event occurred.Contrast was observed to be leaking out of the balloon.Upon removal of the balloon, physical inspection revealed that the balloon had ruptured causing it to leak the contrast.A balloon from another manufacture was used to complete the procedure.No patient injury was reported as a result of the event.

Event Description

Additional information was received: the balloon was tested prior to use and performed as intended.During inflation the guidewire was advanced >5cm out of the catheter tip.Balloon leak occurred at the tip.Contrast ratio was 50/50.The guidewire tip was shaped by the physician.Injectio rate was steady.Syringe was a 1ml medallion.

Manufacturer Narrative

Additional information: device evaluation analysis found the hyperglide occlusion balloon catheter was returned for analysis within a shipping box; within two resealable pouches and without a dispenser coil.A guidewire was found within the balloon catheter and an rhv and 1ml syringe was attached to the hub.The guidewire was found stuck within the balloon catheter.The guidewire was found extending out from the balloon catheter ~6.8cm.When attempting to inflate the balloon using the returned syringe, a leak was found on the returned rhv.The rhv was replaced with an in-house rhv.A rupture was found on the balloon subassembly distal to the distal marker band.Water was found to be leaking out of the rupture.Based on the device analysis and reported information, the customer¿s report of ¿balloon rupture during procedure¿ was confirmed; however, 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.

• Brand Name: HYPERGLIDE
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9214649
• MDR Text Key: 207608084
• Report Number: 2029214-2019-01046
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K092495
• 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: 12/15/2019

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: 12/04/2020
• Device Model Number: 104-4310
• Device Lot Number: A651288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1