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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER

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AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012402-12A
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262); Foreign Body In Patient (2687)
Event Date 03/03/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported the patient presented with cardiac arrest, hemodynamic instability and placed on heart pump for an emergent procedure to treat a chronic totally occluded (cto) lesion in the left anterior descending (lad) and a cto lesion with moderate tortuosity and heavy calcification in the circumflex (cx). The lad was successfully treated. A 1. 5 x 12 mm mini trek balloon catheter was advanced without resistance to treat the cx. After pre-dilatation, during the attempt to remove the balloon catheter, it was noted that the balloon was stuck on the calcified lesion. The balloon was inflated and deflated multiple times to release the balloon from the vessel. The physician pulled on the balloon catheter without force and the balloon catheter was released. However, only the proximal shaft was withdrawn, the distal shaft had separated and remained stuck in the vessel. The patient went into cardiogenic shock, intermittent cardiopulmonary resuscitation (cpr) was performed and the patient became stable. It was decided to abort the procedure and not remove the separated portion from the patient's anatomy as the cx never had blood flow. The patient was sent to intensive care unit and died later that day. Reportedly, the patient was critically ill prior and after the procedure and the cause of death was myocardial infarction (mi). No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported separation was confirmed; however, the reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances. The investigation determined the reported difficulties, foreign body in patient, myocardial infarction, cardiogenic shock and additional treatment appear to be related to circumstances of the procedure. The reported patient effects of death and myocardial infraction as listed in the coronary dilatation catheter, mini trek ii otw, instructions for use are known adverse event associated with the use of the device in the coronary arteries. However, a conclusive cause for the reported patient effect of death and the relationship to the product, if any, cannot be determined. 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 incidents from this lot. 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 NameMINI TREK II OTW 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 Key7370976
MDR Text Key103512364
Report Number2024168-2018-02178
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 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1012402-12A
Device Lot Number70830G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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: 03/26/2018 Patient Sequence Number: 1
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