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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
Model Number 1012448-12
Device Problems Inflation Problem (1310); Leak/Splash (1354); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported inflation problem was able to be confirmed. Additionally during device analysis, it was noted that the outer member was stretched and the inner member was torn above the proximal seal. 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 from this lot. As there was no report of a leak during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guide wire/other devices in conjunction with interaction with the heavily tortuous and mildly calcified lesion resulted in the noted torn inner member; thus resulting in the reported inflation problem/noted tip leak. Manipulation of the device resulted in the noted stretched and folded outer member. 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 to treat a heavily tortuous and mildly calcified lesion in the left circumflex artery. The 2. 75x12mm nc trek balloon catheter (bdc) was advanced. Several attempts to inflate the balloon to nominal pressure were made; however, balloon failed to inflate. Another 2. 75x12mm nc trek bdc was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. The returned device analysis identified that the outer member was stretched proximal to the proximal seal, the inner member above the proximal seal was torn, and fluid was observed coming out of the tip. No additional information was provided.
 
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Brand NameNC TREK 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 Key10160534
MDR Text Key195363802
Report Number2024168-2020-05094
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012448-12
Device Catalogue Number1012448-12
Device Lot Number90822G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2019
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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