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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 1012272-20
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Thrombosis (2100); Ventricular Fibrillation (2130); Pericardial Effusion (3271)
Event Date 12/21/2018
Event Type  Death  
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 was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional graftmaster device referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a proximal left anterior descending artery (lad). Kissing balloon technique was performed at the first diagonal. A 2. 5x20mm trek balloon dilatation catheter was advanced in the diagonal artery and ruptured during the first inflation at 18 atmospheres. A pericardial effusion was then noted. It was attempted to puncture and drain the leak, but did not resolve. An unspecified rx graftmaster was implanted to cover an arterial dissection in the proximal lad. The systolic pressure was 6 and increased to 14 during a span of 15 minutes with a compression image at the lad stent level. Then a dissection was observed in the proximal lad again. It is unknown if the rx graftmaster exacerbated the existing dissection. Hemodynamic condition became worse and ventricular fibrillation started. Several attempts were made to resuscitate the patient including administration of adrenalin but the patient died despite all attempts. An autopsy was not performed. Per the physician, the trek balloon caused or contributed to the pericardial effusion and death. No additional information was provided. Cine images were received and reviewed by a clinical specialist who identified thrombus in both the proximal lad and diagonal arteries. Additionally, partial recanalization of the diagonal artery was noted but the lad remained occluded.
 
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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 Key8390422
MDR Text Key137823411
Report Number2024168-2019-01666
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number1012272-20
Device Lot Number81029G2
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 Received03/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2018
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: 03/05/2019 Patient Sequence Number: 1
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