MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C OCCLUSION BALLOON (4X20 MM); BALLOON CATHETER

Model Number BC0420C

Device Problem Device Handling Problem (3265)

Patient Problems Infarction, Cerebral (1771); Embolus (1830)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment, not diagnosis.The scepter c and scepter xc occlusion balloon catheters are intended for use in the peripheral and neuro vasculature where temporary occlusion is desired.The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.The balloon catheters also offer balloon assisted embolization of intracranial aneurysms.Per the instructions for use: potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudo aneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.Contraindications: not intended for embolectomy or angioplasty procedures, not intended for use in coronary vessels, not intended for pediatric or neonatal use.The device involved in the event will not be returned for evaluation.The complaint cannot be confirmed.(b)(4).

Event Description

It was reported from (b)(6) that during the treatment of a dural av fistula, antegrade embolization of carotid cavernous fistula (ccf) via one branch of the left ica.During liquid embolic occlusion, the liquid embolic flew back into ica then distally, flow in the left media area.Some of the solidified liquid embolic was successfully withdrawn using retrieval devices.The patient suffered several small strokes.On (b)(6) 2015 the patient condition was reported to be better.

• Brand Name: SCEPTER C OCCLUSION BALLOON (4X20 MM)
• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: bill wiggins ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 5128724
• MDR Text Key: 27519740
• Report Number: 2032493-2015-00154
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: BC0420C
• Device Lot Number: 14061122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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): Required Intervention
• Patient Age: 56 YR