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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. LAUNCHER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC. LAUNCHER CATHETER, PERCUTANEOUS Back to Search Results
Model Number LA6JR40
Device Problems Material Puncture/Hole (1504); Gas Leak (2946); Material Deformation (2976)
Patient Problem Myocardial Infarction (1969)
Event Date 07/26/2019
Event Type  Malfunction  
Event Description

A jr4 catheter was used to engaged the right coronary artery for a stent placement. The site was predilate, stented and post dilated without complication. During post angiogram of the right coronary artery, bubbles were sent down the vessel. St elevation was noted on the ekg. Slow flow was noted in the vessel. Intracoronary nitroprusside was administered. Patient was started on a levophed drip. St elevation resolve with ic nipride. A kink/hole was noted on the catheter by the physician. The physician concluded that the kink/hole on the catheter could of cause the bubbles. Spoke with cardiac catheter lab clinical manager. During catheterization, the proceduralist was attempting to manipulate the catheter guide in a normal fashion to maintain access. During this manipulation, the line was thought to have become kinked which led to the above incident. After needed interventions, the patient had a favorable outcome. Patient remains in house for observation purposes.

 
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Brand NameLAUNCHER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
37a cherry hill dr
danvers MA 01923
MDR Report Key8905820
MDR Text Key154725374
Report Number8905820
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLA6JR40
Device LOT Number0009768419
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2019
Event Location Hospital
Date Report TO Manufacturer08/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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