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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012453-15
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported separation and difficulty removing the device appear to be related to operational context. 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 proximal right coronary artery. During post-dilatation, after the 4. 0 x 15 mm nc trek was inflated three times, the proximal end of the balloon did not deflate. An attempt was made to remove the balloon catheter through the guiding catheter, but it could not be removed. When the balloon was pulled back through the 6f radial sheath, the balloon separated from the outer member. The separated balloon was removed with the balloon catheter and guiding catheter as a single unit. The procedure ended at this point. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7311125
MDR Text Key101501859
Report Number2024168-2018-01535
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012453-15
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 Received02/08/2018
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

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