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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
Catalog Number 1012272-15
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The investigation determined the reported complaint appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a target lesion in the heavily calcified left anterior descending (lad) artery. The trek dilatation catheter was inflated to 4 atmospheres (atm) and the balloon ruptured on the first inflation. The device was removed from the anatomy without difficulty. A second same device was used to complete dilatation. There was no adverse patient effect and no clinically significant delay. 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 Key9513794
MDR Text Key178176208
Report Number2024168-2019-14965
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
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012272-15
Device Lot Number90903G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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