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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 1012278-12
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/04/2021
Event Type  Injury  
Manufacturer Narrative
The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the patient was admitted with myocardial infarction. Angiography noted that the mid right coronary artery (rca) was 100% occluded with clot, and the rca ostium was 99% occluded. A non-abbott guide catheter extension was used. Stenting was performed using non-abbott stents. The 4. 0 x 12 mm trek dilatation catheter was advanced for post dilatation of a non-abbott stent. The balloon was inflated without issue and was thought to be deflated without issue. An attempt was made to remove the trek dilatation catheter; however, it was noted that the balloon remained partially inflated and separated in the anatomy. It is unknown what caused the balloon separation; however, it was reported that during the procedure, when the guide catheter extension was removed, some of the non-abbott stent struts became flared. An attempt was made to remove the balloon; however, this was unsuccessful. The plan was made to possibly send the patient for surgical intervention. The patient was transferred to his room and was in stable condition. There was good blood flow around the separated balloon segment. The patient will undergo catheterization on (b)(6) 2021, and the decision will be made if additional intervention is required. 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 Key12544321
MDR Text Key273763431
Report Number2024168-2021-08709
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012278-12
Device Catalogue Number1012278-12
Device Lot Number00813G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2020
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: 09/28/2021 Patient Sequence Number: 1
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