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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 1012449-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: guide wire: runthrough, sion blue, guide cath: al1. 0 , other: guideliner. The device was not returned for evaluation. 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. Based on the information reviewed, there is no indication of a product quality issue. The investigation was unable to determine a conclusive cause for the reported complaints.
 
Event Description
The procedure was to treat a 99% stenosed, eccentric de novo lesion in the mid left anterior descending (lad) coronary artery. Due to heavy tortuosity and heavy calcification, a non-abbott child catheter was used the deliver the devices. During advancement of the 3. 00 x15 mm nc trek balloon dilatation catheter (bdc) along the non-abbott child catheter, heavy resistance between the two was felt. Resistance was also felt while attempting to remove the bdc from the child catheter. Therefore; both the bdc and the child catheter were removed together and replaced. A new 3. 00 x15 mm nc trek bdc was advanced to the lesion along a new non-abbott child catheter without issue. The procedure was completed successfully. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. 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 Key5890801
MDR Text Key52641203
Report Number2024168-2016-05566
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151873
UDI-Public(01)08717648151873(17)180630(10)50721G1
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 company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number1012449-15
Device Lot Number50721G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2015
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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