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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 Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Ventricular Tachycardia (2132)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a mildly calcified right coronary artery. A 4. 0 x 12 mm nc trek balloon catheter was used and did not meet any resistance during advancement. However, after the balloon was deflated, it met resistance with a guiding catheter during removal. Force was used and the device separated at the guide wire exit notch. Therefore, the proximal part of the device was simply withdrawn and the distal part was removed with a snare device. The patient experienced tachycardia before the device separation, which resolved on its own. There was a clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. The reported detachment was able to be confirmed. The reported difficult to remove was unable to 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. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. Force applied resulted in the noted tip detachment. It should be noted that the nc trek rx, global instructions for use states: do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Failure to follow these steps and/ or applying excessive force to the delivery system can potentially result in loss or damage to the stent and/ or delivery system components. Although it was noted that resistance was noted during retraction of the device, this was due to resistance with a guiding catheter therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties. The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire. Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial report, additional information was received. Returned device analysis revealed that a 2. 0 x 15 mm mini trek balloon catheter was returned. It was reported that the device was used to remove the separated portion of the nc trek balloon catheter. 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)
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 Key8144236
MDR Text Key129745728
Report Number2024168-2018-09471
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,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number1012453-12
Device Lot Number80928G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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