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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER CORONARY CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER CORONARY CATHETER Back to Search Results
Model Number 1012276-30
Device Problem Fracture (1260)
Patient Problems Intimal Dissection (1333); Low Blood Pressure/ Hypotension (1914); Occlusion (1984); Respiratory Distress (2045); Foreign Body In Patient (2687)
Event Date 12/23/2016
Event Type  Injury  
Event Description
Patient is found to have severe ulcerated plaque in the left main and high-grade disease in the lad as was seen with previous angiography. A 0. 014 balance wire was placed into the lad; a 0. 014 pt2 wire was placed into the ramus intermedius; a 0. 014 prowater wire was placed into the circumflex balloon. Angioplasty was performed in the lad using a 3. 5 x 30mm balloon. On withdrawal of the balloon into the guide catheter the balloon fractured leaving a fragment of the balloon in the left main coronary artery. The patient became immediately unstable and hypotensive. Maximum support was given from the impella device. Attempts to retrieve the deep balloon fragment were unsuccessful and guide catheter and wires were lost. Patient was intubated and given pressors. A new 7 fr. Guide catheter was used to engage l coronary artery, a 0. 014 balance wire was placed in the lad, brief injection demonstrated almost no flow in the l main. A wire was placed in the ramus intermedius as well as balloon angioplasty with a 35 x 12 balloon in the lad and in the left main, which restored flow. There was clear-cut dissection of the l main and the balloon fragment was wedged in the bifurcation of the l main with proportion stuck in the lad. A 4mm gooseneck snare over a pt2 long wire was used to snare the balloon fragment and was subsequently removed, fully intact. The balloon was examined carefully to show that all pieces were intact. Following removal the procedure moved forward with further intervention as planned. Procedure time increased by approximately 3 hours and patient required dialysis, in part, due to the hypotension and increased creatine due to the increased contrast used during the procedure due to the device failure. Ref #2024168-2017-00521.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside drive
santa clara CA 95054
MDR Report Key6263051
MDR Text Key65426314
Report NumberMW5067308
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 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model Number1012276-30
Device Lot Number51102G1
Was Device Available for Evaluation? No
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: 01/17/2017 Patient Sequence Number: 1
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