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

Model Number	104-4112
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9774241
• Report Number: 2029214-2020-00179
• Device Sequence Number: 19379482
• Product Code: MJN
• UDI-Device Identifier: 00847536004863
• UDI-Public: 00847536004863
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K021066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: 104-4112
• Device Lot Number: A848770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1