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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 1012447-15
Device Problems Difficult To Position (1467); Physical Property Issue (3008); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: sion blue, athlete wizard 78, guide catheter: hyperion 7fr al1. 0. Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported irregular appearance (lifted material) and difficult to position were confirmed. Additionally, there was a hole in the inner member on the inner side, at the distal end of the lifted material. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A review of the complaint history identified no other incidents from this lot. The investigation determined the reported complaints appear to be related to circumstances of the procedure. 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 100% stenosed, moderately tortuous and moderately calcified concentric restenosis lesion in the right coronary artery. The lesion was pre-dilated with a 1. 25x10mm non-abbott balloon dilatation catheter (bdc) and a 2. 5x15mm nc trek bdc. It was confirmed through intravascular ultrasound (ivus) that the lesion was not dilated enough and an attempt to re-advance the 2. 5x15mm nc trek bdc was made. When the guide wire was being inserted into the guide wire exit port of the nc trek, there was resistance felt around the guide wire exit port. The guide wire exit port was checked and flaring was noted. The 2. 5x15mm nc trek bdc was replaced with a 2. 75x15mm nc trek bdc to perform additional dilatation. The procedure was successfully completed after the lesion was dilated with two bdc's. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided. Return device analysis revealed there was a hole in the guide wire exit notch.
 
Manufacturer Narrative
(b)(4). Evaluation summary: revised evaluation: the device was returned for analysis and abbott vascular (av) identified a hole in the inner member, which prevented the guide wire from exiting the notch. Further assessment per site operating procedures was performed and identified a potential product deficiency related to the manufacture of the device. Av determined that this issue does not demonstrate to be systemic across all products. Av will continue to trend the performance of these devices.
 
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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 Key6288263
MDR Text Key66358802
Report Number2024168-2017-00791
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151767
UDI-Public(01)08717648151767(17)190731(10)60818G1
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012447-15
Device Lot Number60818G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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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