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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012280-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. 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 patient was diagnosed with pulmonary arterial hypertension in the course of chronic thromboembolism and narrowed pulmonary artery. A 5. 0x15mm trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use, and a 50/50 contrast mix was used, however, resistance was felt when removing the protective sheath. The bdc was advanced, and inflated once to 6 atmospheres. An attempt was made to deflate the balloon by pulling a negative for 50-60 seconds a few times, but failed. After several unsuccessful attempts the bdc was removed partially deflated, and resistance with the anatomy was felt. The bdc was removed as a unit with the introducer sheath, guide catheter, and bmw guide wire. The procedure was successfully completed, and the patient is okay. There were no adverse patient effects, and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameTREK CORONARY DILATATION CATHETER
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 Key10665529
MDR Text Key210912105
Report Number2024168-2020-08496
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodePL
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012280-15
Device Catalogue Number1012280-15
Device Lot Number00402G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
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: 10/12/2020 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: MEDTRONIK LAUNCHER; GUIDE WIRE: BMW; INTRODUCER SHEATH: BALTON 80CM
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