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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 1012279-15
Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Patient Problems Pain (1994); Obstruction/Occlusion (2422)
Event Date 04/08/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other trek rx device referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a lesion located in the left iliac artery that was heavily calcified. Using contra-lateral approach with a lima coronary guide catheter, a 4. 5x15mm trek rx balloon dilation catheter was advanced to the lesion with some resistance noted. After use, during device removal against resistance, a portion of the balloon separated and remained in the leg. Intravascular ultrasound (ivus) showed blockage of flow in the artery and claudication in the knee. Another stent was advanced and implanted to embed the separated balloon material into the artery. Another 4. 5x15mm trek rx balloon dilation catheter was advanced to post dilate the stent. Resistance was noted during device removal and the shaft separated outside the patient. There was no adverse patient sequela. 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 Key14253437
MDR Text Key290420474
Report Number2024168-2022-04670
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012279-15
Device Catalogue Number1012279-15
Device Lot Number90925G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2019
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: 04/29/2022 Patient Sequence Number: 1
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