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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 1012272-20
Device Problem Material Rupture (1546)
Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative
Visual and functional inspections were performed on the returned device. The reported balloon rupture was confirmed. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The investigation determined the reported balloon rupture appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the left anterior descending artery. The 2. 5x20mm trek rx balloon dilatation catheter was prepared per the instructions for use without issues; however, the balloon ruptured during the fourth inflation at 6-8 atmospheres. The procedure was successfully completed with the deployment of a 2. 5x28mm unspecified stent. 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 Key11418181
MDR Text Key239710331
Report Number2024168-2021-01729
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138300
UDI-Public08717648138300
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-20
Device Catalogue Number1012272-20
Device Lot Number00420G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
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: 03/04/2021 Patient Sequence Number: 1
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