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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012273-15
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2016
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 is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the mildly tortuous left anterior descending (lad) coronary artery. The 2. 75x15mm trek rx balloon dilatation catheter (bdc) was being advanced over a non-abbott guide wire, the kissing balloon technique was being used. However, resistance was encountered with the guide catheter, and the shaft separated. The separation occurred while inside the guiding catheter. The trek bdc had not exited the guide catheter. The separated segments of the trek bdc and the guide catheter were withdrawn together. A new trek bdc was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). It was initially reported that the device would be returned for analysis. Subsequent information revealed that the device was discarded and is not available for evaluation. The device was not returned for analysis. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
 
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Brand NameTREK 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 Key6030705
MDR Text Key57625527
Report Number2024168-2016-06946
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
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 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number1012273-15
Device Lot Number60319G1
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 Received11/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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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