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

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.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, 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 Key: 6973204
• MDR Text Key: 90081598
• Report Number: 1220452-2017-00106
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K021256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LA6JCL35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/24/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 38 YR