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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012276-20
Device Problems Off-Label Use (1494); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. (b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a left femoropopliteal bypass artery. After successful use of an armada balloon dilatation catheter, the trek rx balloon was advanced without resistance, but wrapped around a 0. 014 sparta core wire and the tip of the balloon separated. The devices were removed without resistance. Snaring of the separated portion was attempted, but unsuccessful and the separated portion was left free-floating in the anatomy. A right groin angiogram was performed and showed good flow with no flow limitation to the common femoral artery in the right groin. Patient was transferred to recovery area in stable condition with no complaint of pain or discomfort. The patient will undergo ultrasound in the coming weeks to ensure that there is no limiting flow and to ensure that the patient is not experiencing any adverse effects. No additional information was provided.
 
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Brand NameTREK RX CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9468774
MDR Text Key175023761
Report Number2024168-2019-14526
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model Number1012276-20
Device Catalogue Number1012276-20
Device Lot Number90408G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2019
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: 12/13/2019 Patient Sequence Number: 1
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