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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012453-20
Device Problems Deflation Problem (1149); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional nc trek device is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a lesion in the right coronary artery. The 4. 00x20mm nc trek balloon dilatation catheter (bdc) was prepped outside the anatomy and the contrast mix ratio was 50/50. The bdc was inflated once to dilate the artery. After inflation, the balloon failed to deflate and could not be retrieved into the guiding catheter and could not advance further in the radial artery. A surgeon was called and a cut down was performed to retrieve the balloon from the radial artery. A second 4. 00x20mm nc trek bdc was also prepped outside the anatomy and the contrast mix ratio was 50/50. The bdc was advanced through a 6f guiding catheter through access on the other side via the left radial artery. The bdc was inflated five times at 20 atmospheres. Although negative pressure was held for 15 seconds, the bdc only partially deflated. The bdc was able to be retracted into the guiding catheter and both were removed from the patient anatomy as a single unit. The procedure was successfully completed with the patient in good condition. There were no adverse patient sequela and a procedural delay of three hours occurred due to the surgical intervention for the first trek balloon. No additional information was provided.
 
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Brand NameNC TREK 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 Key10373806
MDR Text Key202009913
Report Number2024168-2020-06573
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-20
Device Catalogue Number1012453-20
Device Lot Number00121G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2020
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: 08/06/2020 Patient Sequence Number: 1
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