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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 1012448-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the moderately calcified, moderately tortuous left anterior descending artery. The 2. 75 x 15 mm nc trek was intended to be used for post-dilatation; however, after several attempts were made to cross, the balloon catheter failed to cross the lesion. Force was applied during the attempt to cross which resulted in kinking of the proximal and distal shaft. The nc trek was removed from the patient as a whole unit. Resistance was felt during access and removal, due to the interaction with the vessel. Once the balloon catheter was removed, it was observed that the distal shaft had separated. Another balloon catheter was used to complete the procedure. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual and dimensional inspections were performed on the returned device. The reported kink and separation were confirmed; however, the reported failure to advance and difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances. It was reported that force was applied against the resistance and the nc trek balloon dilatation catheter (bdc) became kinked at the proximal and distal shaft. It should be noted that the nc trek rx, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter. In this case, it is likely that the use of force during advancement of the bdc resulted in the shaft kinking. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported kinks appear to be related to user error; however, the shaft separation, failure to advance and difficulty removing the device from the anatomy appears 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.
 
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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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key7594016
MDR Text Key111158016
Report Number2024168-2018-04426
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number1012448-15
Device Lot Number70417G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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