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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012272-12
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2020
Event Type  malfunction  
Manufacturer Narrative
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 procedure was performed to treat a moderately calcified, moderately tortuous diagonal 1 branch off of the left anterior descending artery. The 2. 50x12mm trek balloon markers were not visible under fluoroscopy. The device was removed and a new unspecified balloon was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
Visual, functional and dimensional testing were performed on the device. The reported difficulty to position due to no visibility during fluoroscopy was not confirmed. 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 similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulty positioning (no visibility during fluoroscopy) as no visibility issues could be confirmed. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameTREK RX
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 Key9898288
MDR Text Key185729619
Report Number2024168-2020-03092
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
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-12
Device Catalogue Number1012272-12
Device Lot Number91029G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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