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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER
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ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013158-08
Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a moderately calcified and heavily tortuous vessel in the right coronary artery (rca).The 4.5x8mm nc traveler balloon dilatation catheter (bdc) could not be deflated.The bdc was not prepared (air aspiration) outside the anatomy prior to use.There was no difficulty removing the stylet or protective sheath.The procedure was stopped and the balloon was withdrawn inflated together with the guiding catheter.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
 
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.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a moderately calcified and heavily tortuous vessel in the right coronary artery (rca).The 4.5x8mm nc traveler balloon dilatation catheter (bdc) could not be deflated.The bdc was not prepared (air aspiration) outside the anatomy prior to use.There was no difficulty removing the stylet or protective sheath.The procedure was stopped and the balloon was withdrawn inflated together with the guiding catheter.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, it was stated that: there was no difficulty removing the nc traveler and there was no inner member separation noted.No additional information was provided.
 
Manufacturer Narrative
Visual inspection was performed on the returned device.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.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 the coronary dilatation catheters (cdc), nc traveler rx, global, costa rica, 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 compliant.The investigation was unable to determine a conclusive cause for the reported deflation issue.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 TRAVELER 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 Key13763186
MDR Text Key287402212
Report Number2024168-2022-02638
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Followup
Report Date 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue Number1013158-08
Device Lot Number10408G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDING CATHETER
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