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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN UNKNOWN NAVIEN INTRACRANIAL SUPPORT CATH CATHETER, PERCUTANEOUS

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MEDTRONIC COVIDIEN UNKNOWN NAVIEN INTRACRANIAL SUPPORT CATH CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 10/14/2015
Event Type  Injury  
Manufacturer Narrative

The device model and lot numbers were not reported. The device was not returned; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event. Vessel spasm is a known inherent risk of endovascular procedure and is documented in the navien instruction for use.

 
Event Description

Medtronic received information that a patient experienced a catheter induced vasospasm during treatment of an aneurysm located in the clinoid segment of the right internal carotid artery (rica). It was reported that there was immediate resolution after verapamil treatment there was no malfunction of the device during this event. The patient was discharged the following day at baseline.

 
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Brand NameUNKNOWN NAVIEN INTRACRANIAL SUPPORT CATH
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine 92618
9498373700
MDR Report Key5338205
MDR Text Key34780652
Report Number2029214-2015-05245
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/31/2015 Patient Sequence Number: 1
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