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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 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. The investigation was unable to determine a conclusive cause for the reported difficulties. An image from the procedure was received and reviewed by an abbott clinical specialist. The reviewer concluded that from the image provided, it is not able to be determined that the elite guide wire was separated. The proximal portion of the wire is not radiopaque and thus the wire labeled elite could be intact. No images were provided showing the original location or movement with removal of the resolute integrity or nc trek. 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 reported from this lot. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The hi-torque bmw referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a lesion located in the proximal circumflex artery. A buddy wire technique was utilized with the hi-torque balance middleweight (bmw) elite guide wire and a non-abbott guide wire in the lower circumflex and a non-abbott stent was deployed. After deployment of the non-abbott stent, during advancement of the bmw guide wire, it met resistance with the nc trek 3. 0 x 15 mm balloon dilatation catheter that was being used for post-dilatation and separated in two pieces. When the nc trek 3. 0 x 15 mm bdc was being pulled out, resistance was felt again; however, the guide wire and separated components were pulled out together at the same time with no separated guide wire left in the vessel. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. 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 Key6549066
MDR Text Key74667315
Report Number2024168-2017-03970
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151873
UDI-Public(01)08717648151873(17)191231(10)70106G1
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number1012449-15
Device Lot Number70106G1
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 Received04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
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: 05/05/2017 Patient Sequence Number: 1
Treatment
GUIDE WIRE: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
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