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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012452-20
Device Problem Material Rupture (1546)
Patient Problems Air Embolism (1697); Ventricular Tachycardia (2132)
Event Date 11/11/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (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 performed to treat a mildly calcified lesion in the proximal left anterior descending artery. A 3. 75x20mm nc trek rx balloon dilatation catheter (bdc) was being used to post-dilate a 3. 5mm non-abbott stent; however, the balloon ruptured at about 4-6 atmospheres. Several small air bubbles escaped into the vessel. The patient then experienced ventricular tachycardia (not-sustained or requiring shock) and it resolved quickly. The balloon was removed intact without further incident. The procedure was completed with successful post-dilatation of the stent with a new 3. 75x20mm nc trek bdc. The patient is fine and well today. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TREK RX
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 Key9411439
MDR Text Key169136074
Report Number2024168-2019-14118
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012452-20
Device Catalogue Number1012452-20
Device Lot Number90708G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2019
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: 12/04/2019 Patient Sequence Number: 1
Treatment
3.5MM ORSIRO STENT
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