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

Model Number 104-4113

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device will not been returned for analysis as it was discarded by the customer; therefore the cause of this event could not be determined.The investigation is ongoing and the results will be sent upon completion.

Event Description

Medtronic received information that during preparation of a cerebral aneurysm embolization procedure, the physician confirmed the hyderglide balloon ruptured prior to use.Another device was opened to continue the procedure.There was no patient injury as a result, detected prior to use.No further information was provided.Device will not be returned, scrapped on site.

Manufacturer Narrative

Type of report - follow-up.Type of follow-up - additional information.Evaluation codes.Additional information they hyperglide balloon catheter and x-pedion-10 guidewire were not returned for analysis as they were discarded at the site; therefore, the complaint could not be confirmed.Based on the reported information, user error likely contributed to the reported event as a non-cadence syringe was used and the balloon was inflated above the recommended volume.The lot history record review showed no discrepancies that would have contributed to the reported experience.Per the occlusion balloon catheter instruction for use: ¿attach rhv and syringes to balloon.Use cadence syringe with 3 way stopcock and 3cc syringe.To inflate the balloon, use the 1 cc syringe to gently infuse the desired volume of recommended contrast solution.Do not exceed the maximum recommended inflation volume as balloon rupture may occur.¿ 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.

Manufacturer Narrative

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 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5527727
• MDR Text Key: 41220371
• Report Number: 2029214-2016-00167
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2016

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: 04/22/2016
• Device Model Number: 104-4113
• Device Lot Number: 9815356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided; 02/28/2016
• Supplement Dates FDA Received: 05/09/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2013
• 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