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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 1012449-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Cardiac Tamponade (2226)
Event Date 04/23/2019
Event Type  Death  
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 reported patient effects of death and perforation are listed in the coronary dilatation catheters, nc trek rx, instruction for use, as known patient effects. A review of the lot history record could not be conducted because the lot number was not provided. A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery. During preparation of the artery a non-abbott atherectomy system was used and followed by pre-dilatation with a 3. 0x20mm nc trek balloon dilatation catheter; however, a perforation was noted. The perforation caused a pericardial effusion which resulted in cardiac tamponade. Pericardiocentesis was performed; however, the patient expired. 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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key8597008
MDR Text Key144610634
Report Number2024168-2019-03717
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
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1012449-20
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 Received04/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/09/2019 Patient Sequence Number: 1
Treatment
ATHERECTOMY: ROTABLATOR
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