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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 1012445-12
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: dilatation catheter: emerge 2. 5x15, guide catheter: xb 3. 5 6 f guide. (b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that a non-abbott dilatation catheter was in the left anterior descending (lad) coronary artery. An nc trek dilatation catheter attempted to advance to the marginal coronary artery for kissing balloon technique; however, during advancement, resistance was noted with the guide catheter and the device position in the anatomy. The nc trek became kinked. During removal, no resistance was felt; however, the shaft separated while in the guiding catheter. Reportedly, the nc trek catheter was possibly loaded into the guidewire at the beginning of the procedure with minor kinks. The guide catheter and dilatation device were removed as a single unit. There were no adverse patient effects and there was no clinically significant delay. There were no other issues noted. There was no additional information regarding this device issue.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation was confirmed. The reported kink was not confirmed; however, it is likely that the reported kink was located at the separated location noted during return analysis. The reported difficulty to position over the guide wire was not confirmed. The reported difficulty to position with the guiding catheter could not be replicated in a testing environment due to the condition of the returned device. 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 identified no other similar incidents from this lot. The coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: do not use, or attempt to straighten a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. The investigation determined the reported kink and difficulty positioning the device with the guiding catheter appear to be related to circumstances of the procedure; however, the shaft separation appears to be related to user error and 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 Key6478393
MDR Text Key72570975
Report Number2024168-2017-03004
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number1012445-12
Device Lot Number61004G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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