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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 1012454-15
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 11/29/2016
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 relevant information.
 
Event Description
It was reported the procedure was to treat a lesion with no tortuosity and mild calcification in the mid right coronary artery (rca). The 4. 5 x 15 mm nc trek balloon catheter was advanced to the target lesion without resistance noted. The nc trek balloon was inflated to 20 atmospheres two times and there were no issues noted during deflation. However, when the nc trek was to be withdrawn, the balloon could not be retrieved back into the 6fr guiding catheter. The devices had to be withdrawn together as one unit. Outside the patient anatomy, it was noted that the balloon was still partially inflated causing the resistance with the guiding catheter. The patient outcome was good. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported difficulty to remove was confirmed. The partially inflated balloon could not be replicated in a testing environment as it was based on operational circumstances. It should be noted the instruction for use, states: balloon pressure should not exceed the rated burst pressure (rbp). 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 similar incidents from this lot. The investigation determined the reported difficulty removing the device from the guiding catheter appears to be related to circumstances of the procedure; however, a conclusive cause for the reported partially inflated balloon could not be determined. 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 Key6190798
MDR Text Key63201677
Report Number2024168-2016-09048
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 02/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012454-15
Device Lot Number60824G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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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