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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 1012453-08
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2014
Event Type  malfunction  
Event Description
It was reported that during the procedure to treat a lesion in the mid right coronary artery (rca) with moderate calcification and 90% stenosis, an unknown stent was implanted in the lesion and a 2.75x12 mm nc trek dilatation catheter was advanced without resistance and inflated for post-dilatation of the stent; however, the balloon ruptured at 24 atmospheres.Reportedly, the 2.75x12 mm nc trek dilatation catheter was not submerged in heparinized normal saline prior to use.The 2.75x12 mm nc trek dilatation catheter was withdrawn, resistance was felt in the lesion during withdrawal and another same sized nc trek dilatation catheter was advanced and post dilatation was completed successfully.The patient had another lesion in the proximal left circumflex with mild tortuosity, mild calcification and 85% stenosis an unknown stent was implanted and a 4.0x8 mm nc trek dilatation catheter was advanced to post-dilate but the balloon had a refold issue after the first inflation so the physician decided to change to another balloon.The balloon did not refold as expected.Reportedly, the refold issue resulted in a withdrawal issue, resistance was felt with the patient anatomy during removal of the 4.0x8 nc trek dilatation catheter; however, some force was applied and the dilatation catheter was withdrawn from the patient anatomy.A new same sized nc trek dilatation catheter was advanced and inflated; however, the same issue occurred.Reportedly, there was no deflation issue with the 4.0x8 mm nc trek dilatation catheters.When the nc trek dilatation catheter was withdrawn from the patient anatomy a non-abbott device was used to complete the procedure.
 
Manufacturer Narrative
(b)(4).Event description continued: there was no adverse patient effect and no clinically significant delay in the procedure.The patients final outcome was satisfactory.No additional information was provided.The additional 4.0x8 mm nc trek and the 2.75x12 mm nc trek devices referenced are being filed under separate medwatch reports.(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for evaluation.The reported poor refold was confirmed.The reported difficult to remove could not be replicated in a testing environment as it was based on operational circumstances.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint history of the reported lot did not indicate a manufacturing issue.It should be noted that the nc trek instructions for use, warnings section, 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.Based on the information reviewed, there is no indication of a product deficiency.
 
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Brand Name
NC TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key4164098
MDR Text Key4870459
Report Number2024168-2014-06616
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Catalogue Number1012453-08
Device Lot Number40408GA
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/07/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/15/2014
Initial Date FDA Received10/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient Weight73
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