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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 1012276-30
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)
Patient Problems Intimal Dissection (1333); Low Blood Pressure/ Hypotension (1914); Occlusion (1984); Renal Failure (2041); Respiratory Distress (2045); Shock (2072)
Event Date 12/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device is not returning. 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 moderately calcified left main artery. A 3. 5 x 30 mm rx trek balloon catheter was being used for post-dilatation and was inflated 3 times to an unknown atmosphere when it would not deflate. Attempts were made to deflate the balloon but it would not deflate and when removing the device from the anatomy, the balloon separated. The patient became hypotensive and went into shock and was placed on a heart pump and intubated. An injection showed there was almost no flow in the left main. A 3. 5 x 12 mm balloon catheter was inflated in the left anterior descending artery (lad) which restored flow. Additionally, there was a dissection of the left main and the balloon fragment was wedged in the bifurcation of the left main with a portion stuck in the lad. The separated portion was removed with a snare device additionally, the patient had acute renal failure and was given dialysis. Procedure time increased approximately 3 hours and patient required dialysis, in part, due to the hypotension and increased creatine due to the increased contrast used during the procedure due to the device failure. The patient was discharged in stable condition. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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. The reported patient effects of dissection, hypotension and occlusion as listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use are known patient effects. The investigation was unable to determine a conclusive cause for the reported deflation issue and patient effect of respiratory distress; however, the separation and patient effects appear to be related to circumstances of the procedure. 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 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 Key6257402
MDR Text Key64965212
Report Number2024168-2017-00521
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 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number1012276-30
Device Lot Number51102G1
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 Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2015
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: 01/17/2017 Patient Sequence Number: 1
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