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

Model Number 104-4112

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex with shield device did not open at the proximal section.The hyperglide balloon was selected to open the pipeline device.However, the balloon ruptured during the inflation.A new balloon was used to open the pipeline device.No patient injury occurred.The vessel anatomy was normal in tortuosity.The pipeline was place in a curb / bend in the anatomy.

• Brand Name: HYPERGLIDE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9774241
• MDR Text Key: 182171726
• Report Number: 2029214-2020-00179
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00847536004863
• UDI-Public: 00847536004863
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K021066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2020

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: 03/02/2022
• Device Model Number: 104-4112
• Device Lot Number: A848770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2019
• 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