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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 Inflation Problem (1310); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.However, the analysis identified the inner and outer member was stretched and bunched distal to the mid lap seal.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 was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
 
Event Description
It was reported that the procedure was to treat a de novo, moderately calcified, mildly tortuous lesion in the left anterior descending (lad) artery.The 4.0x20 mm nc trek balloon dilatation catheter (bdc) was able to hold pressure but could only partially inflate inside the previously implanted stent.There was no difficulty in removing the stylet or protective sheath.Another nc trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified a stretched inner/outer member.No additional information was provided.
 
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Brand Name
NC TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY 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 Key12378821
MDR Text Key268514482
Report Number2024168-2021-07597
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152085
UDI-Public08717648152085
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number1012453-20
Device Catalogue Number1012453-20
Device Lot Number90226G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received08/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age56 YR
Patient Weight78
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