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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS Back to Search Results
Model Number C315S1002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 07/19/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during the implant procedure, the patient experienced perforation and tamponade at the right ventricular anterior wall and the apex. The patient¿s blood pressure decreased and subsequently lost consciousness and did not respond to the nurse¿s voice. Drainage was performed immediately, and as a result, the pulse rate was improved. The surgeon suspected that the perforation at the right ventricular anterior wall was caused by the catheter, and the other site at the apex was possibly pierced by mistake during drainage. The patient received thoracotomy and was in stable condition. It was noted that myocardial fibrosis was observed while suturing the perforation sites, and the fibrosis was so severe that the myocardium could collapse by a suture needle, which indicated that the patient had a very high risk of perforation. No further patient complications have been reported as a result of this event.

 
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Brand NameDEFLECT
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7782514
MDR Text Key117129826
Report Number9612164-2018-02044
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK101885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC315S1002
Device Catalogue NumberC315S1002
Device LOT Number0009157812
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 Received07/19/2018
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: 08/14/2018 Patient Sequence Number: 1
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