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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 1012453-15
Device Problems Difficult to Remove (1528); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
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 complaints appear 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 this was a procedure to treat a heavily calcified, heavily tortuous and 90% proximal right coronary artery.An nc trek rx 4.0x15mm balloon delivery catheter (bdc) was inserted.However, during advancement, resistance was felt with the lesion.The bdc was unable to cross the lesion; therefore, it was removed.It was noted that resistance was felt during removal.The bdc was replaced with a non-abbott device.There were no adverse patient effects and no clinically significant delay in the procedure.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
MDR Report Key12752886
MDR Text Key280193553
Report Number2024168-2021-09979
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152078
UDI-Public08717648152078
Combination Product (y/n)N
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/04/2021
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 Date09/30/2023
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number01014G1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/13/2021
Initial Date FDA Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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