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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number LA6JCL35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Myocardial Infarction (1969)
Event Date 02/09/2015
Event Type  Injury  
Manufacturer Narrative

Literature title: massive coronary air embolism treated successfully by simple aspiration by guiding catheter. Authors: santosh kumar sinhaa, b, amit madaana, ramesh thakura, umeshwar pandeya, kush bhagata, surendra puniaa literature reference: doi: http://dx. Doi. Org/10. 14740/cr373w. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient presented to the facility with acute anterior wall myocardial infarction of a 2 hour window period. Patient vitals were stable. On the next day coronary angiogram was performed through femoral route. The patient received 2,500 u of heparin intra-arterially. Standard 6f jr4 and jl4 proflo diagnostic catheters were used. Catheterisation of the right coronary artery was uneventful showing a smooth normal coronary artery. There was discrete eccentric lesion of 90% stenosis in the proximal lad artery with thrombolysis in mi (timi) 2 flow with normal appearing left circumflex artery. It was decided to stent lad after proper consent. A proflo diagnostic jl4 was exchanged with a launcher jl 3. 5 cm 6f guiding catheter and connected via a y-adapter to the manifold system. 2-3 ml of blood was allowed to back bleed from the catheter during insertion. A further 7000 u of heparin was given through femoral sheath. When the dye was injected to check the cannulation of left system, air was introduced into both lad and left circumflex because of loose y-adapter connection to manifold. The patient suddenly developed chest pain with st-elevation in v1 to v4 and ii, iii and avf. On the next shot, there was total occlusion of proximal lcx and distal lad. The patient then developed hypertension, bradycardia and asystole. Cardio-pulmonary resuscitation was started and the patient was given 100% oxygen, opiate analgesia and atropine. Vigorous aspiration of approx. 65 ml of blood was done through the guiding catheter after proper connection of y-adapter. The lesion was stented with an endeavor sprint. Cardiac markers were assessed the following day and peri-procedural necrosis was ruled out. The patient is now stable and having regular follow-ups.

 
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Brand NameLAUNCHER 6F GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6973204
MDR Text Key90081598
Report Number1220452-2017-00106
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK021256
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 10/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLA6JCL35
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 Received09/26/2017
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 TREATMENT DATA
Date Received: 10/24/2017 Patient Sequence Number: 1
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