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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 1012272-15
Device Problem Deflation Problem (1149)
Patient Problems Ischemia (1942); Occlusion (1984)
Event Date 06/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. The investigation is not yet complete. 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 mid left anterior descending artery with moderate tortuosity as well as a lesion in a side branch diagonal with moderate tortuosity. A 2. 5x15 trek rx balloon dilatation catheter (bdc) stylet/protective sheath was removed without resistance. Air aspiration was performed outside the anatomy prior to use. The trek was advanced toward the target lesion; the balloon was inflated up to 14 atmospheres for 20 seconds to treat the lesion. An attempt was made to deflate the balloon; however, the balloon completely failed to deflate. The balloon was withdrawn inflated into an unspecified guide catheter and the balloon was removed with the guide catheter as a single unit from the patient anatomy. During the procedure the patient became ischemic due to the side branch diagonal becoming totally occluded. It was suspected that the occlusion was plaque that shifted into the area. An unspecified balloon was advanced toward the side branch diagonal and successfully treated the occlusion. There was no adverse patient sequela. There was no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). Visual, dimensional and functional inspections were performed on the returned device. The deflation issue was confirmed. 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 reported patient effect of occlusion as listed in the coronary dilatation catheter, trek rx and mini trek rx, global, instructions for use is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries. 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 was unable to determine a conclusive cause for the reported deflation issue. The reported patient effects are a known inherent risk of the procedure and the treatment appears 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 Key5753640
MDR Text Key48291688
Report Number2024168-2016-04184
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 06/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number1012272-15
Device Lot Number60301G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? Yes
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

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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