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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
Catalog Number UNK NC TREK
Device Problems Entrapment of Device (1212); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2020
Event Type  Injury  
Manufacturer Narrative
The unique device identifier (udi) is unknown because the part and lot numbers were not provided. The product was not returned to abbott vascular for analysis. A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query was not performed since the lot number was not reported and the device was not returned for analysis. In this case, the device was prepped prior to use and inflated once prior to the balloon rupture without any leaks or ruptures noted. The investigation determined the reported balloon rupture and entrapment of the device appear to be related to operational circumstances of the procedure. Based on the reported information, during the second inflation, the balloon ruptured at 16 atmospheres. It is likely that during the second inflation the balloon became damaged against the previously implanted stent resulting in the reported balloon rupture. The ruptured balloon did not properly refold and became tangled with the stent. Additionally, the treatment appears to be related to the operational context of the procedure as the patient was taken to surgery to remove the device. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the mid right coronary artery (rca). An unspecified stent was implanted and post dilatation was performed using an nc trek dilatation catheter. During the second inflation, the balloon ruptured at 16 atmospheres. The ruptured balloon became tangled with the newly implanted stent. The nc trek could not be removed. The patient was taken for a surgical removal of the device. Post procedure, the patient was in stable condition. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceDILATATION 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 Key10635522
MDR Text Key210009012
Report Number2024168-2020-08293
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK NC TREK
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/06/2020 Patient Sequence Number: 1
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