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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ABBOTT VASCULAR NC TREK CORONARY DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number REF#1012451-20
Device Problem Material Rupture (1546)
Patient Problems Air Embolism (1697); Chest Pain (1776); Diminished Pulse Pressure (2606)
Event Date 10/26/2020
Event Type  Injury  
Event Description
A barbeau type a exam was noted the right wrist. A 6f glidesheath was placed in the right radial artery using modified seldinger technique. 2. 5 mg verapamil was administered intra-arterially via the sheath. A 0. 035 j-wire was used to advance catheters for engagement. Heparin was administered when the catheter crossed into the ascending aorta. I engaged the left main with a 6 french ebu 3. 5 guiding catheter. I then proceeded to perform ifr assessment of both the lad and the left circumflex coronary artery. I used the volcano wire and standard technique. Ifr of the lad was 0. 87 indicating hemodynamic significance. Ifr of the left circumflex was 0. 83 indicating hemodynamic significance. Pci was indicated. I then perform primary stenting of the left circumflex with a 3. 5 x 32 mm synergy drug-eluting stent deployed at 14 atm and postdilated to 14 atm. Excellent angiograph results were obtained. I then rewired the lad with the volcano wire and performed stenting using a 3. 5 x 32 mm synergy drug-eluting stent. This was followed by stenting more proximally using a 3. 5 x 16 mm synergy drug-eluting stent deployed at 11 atm and postdilated to 14 atm. I then returned with a 3. 5 x 20 mm nc trek balloon and performed post dilation of the lad stent. At this time air embolus was noted in the left coronary system. Etiology was not completely clear. There was concern over rupture of the balloon shaft. Patient immediately had chest discomfort followed by pea arrest. This necessitated cpr and acls protocol. Eventually patient had return of consciousness and pulse. Repeat angiography confirmed resolution of air embolus with distal timi-3 flow. Patient did not require intubation. Upon of inspection of the nc trek coronary dilator catheter 3. 50 the sheath was noted to be ruptured. Fda safety report id# (b)(4).
 
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Brand NameNC TREK CORONARY DILATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
athens GA 30606
MDR Report Key10784974
MDR Text Key214778251
Report NumberMW5097625
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberREF#1012451-20
Device Lot Number81076G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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