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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 1012455-12
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2015
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a lesion from the left main trunk (lmt) to the left anterior descending artery (lad).There was no tortuosity and no calcification.A xience xpedition stent was implanted and the 5.0 x 12 mm nc trek balloon catheter was advanced for post-dilatation.Air aspiration of the balloon catheter was performed inside the patient anatomy.The nc trek balloon was inflated to 12 atmospheres (atm) and then deflated.It was noted that the deflation took longer than usual, but the specific time was unknown.The balloon was pulled into the guiding catheter from the lesion before the balloon was fully deflated because the lesion was in the lmt.It was also noted that the balloon was wrinkled and that resistance was noted with the guiding catheter during removal.The procedure was then completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for evaluation.The reported deflation difficulty and wrinkled balloon was confirmed.The reported resistance with the guiding catheter could not be tested due to the condition of the returned device.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 electronic complaint handling database revealed no other incidents for deflation difficulty, resistance with the guiding catheter or wrinkled balloon reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Because it was reported that air aspiration was performed inside the patient, it should be noted that the preparation for use section of the nc trek coronary dilatation catheter instructions for use (ifu) states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.It is unknown if the ifu deviation contributed to the reported difficulties.
 
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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 Key4547428
MDR Text Key5508658
Report Number2024168-2015-01023
Device Sequence Number1
Product Code LOX
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 Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 02/06/2015
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 Date09/30/2017
Device Catalogue Number1012455-12
Device Lot Number41016G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2015
Initial Date FDA Received02/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
STENT: XIENCE XPEDITION
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