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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER
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ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012445-12
Device Problems Break (1069); Material Separation (1562); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a moderately calcified unspecified coronary artery.A 2.0 x 12 mm nc trek balloon catheter was used; however, it became "damaged/broken" during procedure.There were no adverse patient effects.No additional information was provided.
 
Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported popping noise 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 identified no other incidents/complaints from this lot.The investigation determined the reported separation appears to be related to operational context; however, a conclusive cause for the reported popping noise could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a moderately calcified unspecified coronary artery.A 2.0 x 12 mm nc trek balloon catheter was used; however, it became "damaged/broken" during procedure.There were no adverse patient effects.Subsequent to the initial report, additional information was added.The device made a popping sound during a kissing balloon technique and the shaft of the nc trek balloon catheter separated in the hemostatic valve.The components were simply withdrawn.No additional information was provided.
 
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Brand Name
NC TREK RX
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9194704
MDR Text Key172926459
Report Number2024168-2019-12638
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151644
UDI-Public08717648151644
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 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Catalogue Number1012445-12
Device Lot Number70118G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
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