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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 Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2021
Event Type  malfunction  
Manufacturer Narrative
Attachment: (b)(4). The device location was not provided. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
User facility medwatch report (b)(4) received that states "patient admitted with cp x few weeks and found to have st-elevated myocardial infarction stem!. The patient was taken to the catheterization lab for angiography and potential percutaneous intervention. During the procedure, coronary balloon, from nc trek coronary dilatation catheter, could not be removed from guide catheter during angioplasty/stent procedure. The body of the balloon telescoped inside itself and made a hard ridge that got stuck on guideliner making it impossible to be removed from guide catheter. As a result, the entire system had to be removed. Additional notes. Drug-eluting stent placed and post-dilated with a 4. 0 x 15 mm nc trek balloon at high pressure. Health care providers were unable to pull the deflated balloon completely back into the guide, so the entire system was removed as one. The balloon then stuck as it was entering the radial sheath. The balloon was advanced over the wire a bit, inflated to very low pressure, and then successfully withdrawn as it was deflated. Inspection of the balloon revealed that the more distal edge that had failed to assume a lower profile. " additional information was received from the account: it was reported that the procedure was to treat a 100% stenosed vessel in the proximal left circumflex artery. A 6fr guiding catheter was used. The nc trek balloon dilatation catheter (bdc) was not air aspirated outside of the anatomy prior to use. During post dilatation, the nc trek was inflated 3 times with a pressure of 20 atmospheres (atm) each inflation. Negative pressure was held for 15 seconds and it was noted that the balloon deflated so that the distal end was sucked into the center [fold issue]. As a result the bdc could not be removed through the guiding catheter. The nc trek bdc was removed as a single unit with the guide catheter but met resistance at the sheath. The balloon was therefore slightly re-inflated. Upon deflation, the balloon was able to be successfully removed without intervention. There were no adverse patient effects and there was no 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 Key12366164
MDR Text Key268094257
Report Number2024168-2021-07522
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number10213G1
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 Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/25/2021 Patient Sequence Number: 1
Treatment
6F GUIDELINER
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