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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 1012455-15
Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/18/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat the mid and proximal right coronary arteries with severe calcification.The 5.00x15 mm nc trek balloon dilatation catheter (bdc) had a contrast mix of 50/50 and was inflated twice to 20 atmospheres (atm).The balloon was repositioned in the artery between inflations and there was no issue deflating the balloon after the first inflation.After the second inflation, the trek balloon would not deflate at all despite multiple attempts.Negative pressure was applied for 20-30 seconds.A syringe was also used in an attempt to deflate the balloon before it was removed.The balloon was pulled a few times and the entire system was removed (bdc, guide wire).As the balloon was stuck with the guide wire, wire access was lost.The balloon separated at the proximal balloon marker and remained in the patient.Instead of attempting to snare, another guide wire was placed sub-intimally and the balloon was crushed to the vessel wall with 4.00x38 and 4.00x15 mm xience stents.Post-dilatation was performed with another 5.00x15 mm nc trek bdc.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat the mid and proximal right coronary arteries with severe calcification.The 5.00x15 mm nc trek balloon dilatation catheter (bdc) had a contrast mix of 50/50 and was inflated twice to 20 atmospheres (atm).The balloon was repositioned in the artery between inflations and there was no issue deflating the balloon after the first inflation.After the second inflation, the trek balloon would not deflate at all despite multiple attempts.Negative pressure was applied for 20-30 seconds.A syringe was also used in an attempt to deflate the balloon before it was removed.The balloon was pulled a few times and the entire system was removed (bdc, guide wire).As the balloon was stuck with the guide wire, wire access was lost.The balloon separated at the proximal balloon marker and remained in the patient.Instead of attempting to snare, another guide wire was placed sub-intimally and the balloon was crushed to the vessel wall with 4.00x38 and 4.00x15 mm xience stents.Post-dilatation was performed with another 5.00x15 mm nc trek bdc.Subsequently to the initially filed report, the following information was provided: the access was via the radial artery.The nc trek bdc was stuck with the anatomy.The pilot guide wire was used to go sub-intimal in the second portion of the procedure.The 1st xience stent used to crush the balloon was 4.00x30 mm.Post dilatation with the 5.00x15 mm nc trek was performed at 24 atm.No additional information was provided.
 
Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon was inflated twice to 20 atmospheres (atms).It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported difficulty removing the device, balloon separation, device embedded in tissue or plaque and additional treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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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 Key12147619
MDR Text Key262693053
Report Number2024168-2021-05911
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152153
UDI-Public08717648152153
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,health
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number1012455-15
Device Catalogue Number1012455-15
Device Lot Number00706G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Initial Date Manufacturer Received 06/18/2021
Initial Date FDA Received07/09/2021
Supplement Dates Manufacturer Received08/11/2021
Supplement Dates FDA Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6FR GUIDE CATHETER
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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