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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
Catalog Number 1012451-12
Device Problems Deflation Problem (1149); Entrapment of Device (1212); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/23/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The balloon remains in the patient. It is unknown if the shaft of the device is returning for analysis. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an 80% stenosed lesion in the left anterior descending (lad) coronary artery. The 3. 5 x 12 mm nc trek balloon dilatation catheter (bdc) was prepped outside the anatomy prior to use and the contrast mix was 1:1. Reportedly, there was resistance when removing the protective sheath. The bdc was intended to be used for post-dilatation; however, the bdc was unable to inflate at 6 atmospheres (atm). The physician rinsed the inflation device and attempted inflation at 6 atm again. Suddenly, the pressure gauge turned to 12 atm and it was not possible to retract or pierce the bdc in order to deflate it. The balloon was held negative for about 15 seconds after it inflated to 12 atm. Several attempts were made to pierce the bdc but it was stuck in the stent. The patient was transferred to another hospital for treatment; however it was unsuccessful as the bdc still could not be retracted. The patient was then transferred to cardiac surgery and the shaft of the bdc was cut and the balloon was left in the lad. The patient received coronary artery bypass graft (cabg). The patient is still being observed in the hospital. 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 Key9045987
MDR Text Key161030496
Report Number2024168-2019-11791
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Catalogue Number1012451-12
Device Lot Number81204G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2018
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: 09/13/2019 Patient Sequence Number: 1
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