MAUDE Adverse Event Report: COVIDIEN (IRVINE) NV BALLOON; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Device Problem Burst Container or Vessel (1074)

Patient Problems Infarction, Cerebral (1771); Death (1802)

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis.Attempts to gather additional information have been made.However, our attempts were unsuccessful.Based on the reported information, it appears the user caused the reported event, as the balloon was reported to have been over-inflated.Per the device's instructions for use (ifu): do not exceed the maximum recommended inflation volume as balloon rupture may occur.Verify the size of vessel under fluoroscopy, ensuring that when inflated, the balloon does not exceed size of vessel.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report thought literature review of ¿1-hexyl n-cyanoacrylate compound (neucrylate tm an), a new treatment for berry aneurysm.Iii: initial clinical results¿.It was reported that one balloon ruptured during the procedure and contributed to the patient¿s death.There was also a report of difficulties with a balloon, which caused inadequate treatment.Balloon rupture allows contrast in the balloon to come into contact with the polymerizing agent, thereby disrupting it and leading to a high likelihood of downstream embolization.This complication occurred in the one patient in this series who died.In that patient a 4 mm balloon had been overinflated to 7 mm in order to provide optimal neck coverage.The balloon ruptured upon overinflation resulting in downstream embolization of neucrylate material which led to a massive hemispheric infarction and subsequent death.Patient (b)(6): this woman in her late 60s presented with progressive cranial nerve palsy consisting of right ptosis and left eye medial deviation.Her right eye was fixed without any movement in four directions, left lateral gaze was impaired and the pupils were fixed without reaction to light.She was also hypertensive and had migraine headaches for many years.Axial t2-weighted mr image showing bilateral intracavernous internal carotid artery aneurysms with large clot load.Rotational 3-d catheter angiography showing the wide neck of the aneurysm, approximately three times the diameter of the internal carotid artery and, opposite the aneurysm, fusiform dilation of the internal carotid artery itself has occurred.The balloon microcatheters available were smaller than the internal diameter of the carotid artery.Attempted treatment required over inflation of the balloon microcatheter.During the injection of the device the balloon burst causing downstream embolization of the partially polymerized liquid.Immediate follow-up angiography showing the device in the distal internal carotid artery and in branches of the middle cerebral artery.The patient developed massive hemispheric infarction and ultimately died.

• Brand Name: NV BALLOON
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8389891
• MDR Text Key: 137806217
• Report Number: 2029214-2019-00158
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death