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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 1013155-08
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. 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 from this lot. As the balloon deflated correctly after the first and second inflations, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that prior to the third deflation manipulation of the device resulted in compromising the outer member thereby reducing the inflation/deflation lumen thus resulting in the reported deflation problem. There is no indication of a product quality issue with respect to manufacture, design or labeling. The nc traveler is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.
 
Event Description
It was reported that the procedure was to treat a concentric, mildly tortuous, moderately calcified lesion in the distal right coronary artery. Following stent implantation, the 3. 50x8 mm nc traveler balloon dilatation catheter (bdc) was used for post-dilatation but failed to deflate after the third inflation. The balloon was inflated three times at 18 atmospheres, each for 10 seconds. Negative pressure was applied no less than 5 times and when the balloon deflated a little it was retrieved into the guiding catheter that was already present in the anatomy. A non-abbott bdc was used to complete the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TRAVELER 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 Key11174750
MDR Text Key227006478
Report Number2024168-2021-00465
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013155-08
Device Lot Number00107G1
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 Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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