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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 1012449-12
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Ventricular Tachycardia (2132)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative
Patient indeflator: 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 3. 0x12 mm nc trek rx balloon dilatation catheter (bdc) was advanced to the mildly calcified, mildly tortuous, mid left anterior descending coronary artery. The bdc was inflated to 10 atmospheres when a burst of contrast was seen coming out of the distal end of the balloon catheter and the bdc deflated. The same bdc was inflated a second time, but at 12 atms, and the same thing occurred. It was not a balloon rupture of the bdc because it was able to hold pressure and no blood came back into the indeflator. The patient went into ventricular tachycardia from the contrast and air that came out of the bdc. The patient was able to be stabilized and the procedure continued on with a second same size nc trek without further incident. 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 Key8487209
MDR Text Key141051349
Report Number2024168-2019-02687
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
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 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012449-12
Device Lot Number90208G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
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: 04/05/2019 Patient Sequence Number: 1
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