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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX & VOYAGER NC CORONARY DILATATION CATHETER

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ABBOTT VASCULAR NC TREK RX & VOYAGER NC CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012452-20
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2019
Event Type  malfunction  
Manufacturer Narrative
Visual inspection was performed on the returned device. The reported irregular appearance (wrinkled material) could not be confirmed; however, the outer member was stretched proximal from the proximal seal and the inner member was separated at the proximal marker which was likely what the account perceived as the reported complaint. 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 was unable to determine a conclusive cause for the reported complaint. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that prior to use, a 3. 75x20mm nc trek balloon dilatation catheter (bdc) material appeared to be wrinkled. The device was not used and there was no patient involvement. A new same size nc trek was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned device analysis identified that the inner member of the shaft was noted to be separated, but the outer member remained intact.
 
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Brand NameNC TREK RX & VOYAGER NC
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 Key10010144
MDR Text Key189356455
Report Number2024168-2020-03989
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model Number1012452-20
Device Catalogue Number1012452-20
Device Lot Number70810G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2017
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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