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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 1012449-15
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. It was reported that the device was prepped inside the anatomy. It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur. In this case, it is unknown if the ifu violation caused or contributed to the reported complaint. The investigation was unable to determine a conclusive cause for the reported balloon rupture. 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 to treat a mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery. The 3. 0x15mm nc trek balloon dilatation catheter (bdc) was soaked prior to use, however, it was not prepared (air aspirated) outside the anatomy. There was no resistance during advancement. The bdc was inflated once and the balloon ruptured at 18 atmospheres (atms). Another balloon was used to complete the procedure. There was no adverse patient effect and there was no clinically significant delay in the procedure. 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 Key13002324
MDR Text Key285825714
Report Number2024168-2021-11534
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012449-15
Device Catalogue Number1012449-15
Device Lot Number10520G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2021
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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