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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 1012453-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (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 the procedure was to treat a narrow and heavily calcified proximal left anterior descending artery (lad) that had in-stent restenosis of a non-abbott stent and a 95% stenosed circumflex (cx) artery. The restenosis in the lad was treated with a drug-eluting balloon catheter. The cx was pre-dilated with a 2. 5 x 12 mm unspecified balloon catheter to 12 atmospheres. An unspecified 2. 75 x 8 mm drug-eluting stent was deployed at 12 atmospheres. The stent delivery system was left in the anatomy and a 4. 0 x 12 mm nc trek balloon catheter was being advanced for a kissing balloon technique when there was strong resistance felt. The catheter was pushed extremely hard when the proximal shaft, outside the anatomy, separated. The catheter was removed without issue and a new 4. 0 x 12 mm nc trek was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional inspection was performed on the returned device. The shaft separation was confirmed. The difficulty positioning the device could not be replicated in a testing environment as it was based on operational circumstances. 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. It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use 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. The investigation determined the reported difficulty positioning the device appears to be related to circumstances of the procedure; however, the reported shaft separation appears to be related to user error. 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 Key6588403
MDR Text Key76031828
Report Number2024168-2017-04443
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1012453-12
Device Lot Number70302G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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