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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number LAUNCHER(UNK)
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Aortic Dissection (2491)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

A patient presented with high risk unstable angina and was found to have a subtotal occlusion in the mid-proximal rca. It was decided to perform pci on the rca. A 6f jr4 launcher guide catheter was engaged via the right radial artery using a 6f arterial sheath. The sub-occlusion was easily crossed by a non-medtronic guidewire and a non-medtronic bare metal stent was implanted in the mid-proximal rca. A coronary spiral dissection was noted proximal to the stent and back to the right coronary sinus and ascending aorta. It is reported that the dissection was most likely caused by the stent rather than the guide catheter. A spasm in the distal part of the stent was also noted. Abrupt onset of severe chest pain and hypertension occurred. The aortic dissection extended to the ascending aorta and the aortic arch. A second non-medtronic bare metal stent stent was implanted from the first stent to the ostium of the rca, distal rca flow was restored but the entry site of the aortic dissection was not sealed. An extension to the descending aorta occurred during injections. A non-medtronic stent graft was implanted from the rca ostium and sealed the entry site of the aortic dissection. Timi 3 flow was achieved and the patient stabilised. Ecg and haemodynamic changes were quickly back to normal. Immediately af ter the procedure, computed tomography (ct) was preformed and revealed a type iia debakey-stanford aortic dissection, originating from the rca ostium and extending to the descending aorta. Transthoracic echocardiography (tte) was performed and revealed no abnormality. The patient was discharged 4 days later on dapt. A follow-up scan at six months showed complete resolution of the dissection, with full healing of the aorta and absorption of the haematoma.

 
Manufacturer Narrative

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

 
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Brand NameLAUNCHER UNK GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers
ma,us
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers
ma,us
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7734383
MDR Text Key115524016
Report Number1220452-2018-00096
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeRO
PMA/PMN NumberK132673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLAUNCHER(UNK)
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 Received08/08/2018
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: 07/31/2018 Patient Sequence Number: 1
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