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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR RX TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR RX TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012276-30
Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a mildly tortuous lesion in the circumflex artery (cx). The patient presented with an inferior st-elevation myocardial infarction and stent thrombosis in an anomalous cx. The patient had multiple layers of stent and a full metal jacket in the cx. Pre-dilatation was performed with an unspecified small size balloon and good flow was achieved. A comment was made during initial inflations that it was difficult to see the balloon inflate, and a request to increase the contrast mix was made, however it remained at 50:50 concentration. A 3. 5x30mm trek rx balloon dilatation catheter (bdc) was inflated to 18 atmospheres with no concerns. After use, an attempt to deflate the balloon was made; however, it would not deflate, and double negative was performed. The bdc was gently pulled and the shaft separated from the balloon. The separated balloon remained in the ostium of the cx. A trapping balloon was used to attempt and remove the separated balloon, but the balloon would not dislodge. An unspecified 1. 5mm balloon was able to pass below the inflated balloon, gently inflated, and was able to dislodge the separated balloon. Again, a trapping balloon was used and successfully remove the separated balloon from the anatomy. During the procedure the patient had chest pain and st elevation. The chest pain resolved after the balloon was removed and the st elevation was treated with the restoration of flow with other unspecified balloons. A final angiogram was performed, and no additional adverse events were documented, and the patient continues to be okay. A clinically significant delay in the procedure was reported. No additional information was provided.
 
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Brand NameRX TREK
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9776114
MDR Text Key182471478
Report Number2024168-2020-01912
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-30
Device Catalogue Number1012276-30
Device Lot Number90603G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2019
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: 03/02/2020 Patient Sequence Number: 1
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