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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 1012274-20
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Heart Failure (2206)
Event Date 09/18/2020
Event Type  Death  
Manufacturer Narrative
(b)(4). 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. Na.
 
Event Description
It was reported that the patient presented with an st elevated myocardial infarction and the procedure was performed to treat a heavily calcified lesion in the right coronary artery (rca). A 3. 0x20mm trek rx balloon dilation catheter (bdc) was advanced to the lesion with resistance from the calcified anatomy. During the first inflation the balloon of the bdc ruptured at 20 atmospheres. When retracting the bdc, resistance with the anatomy was felt and the balloon separated from the bdc shaft and was stuck in the rca. Several snare devices and unspecified guide wires were used to try to remove the separated segment of the balloon but were unsuccessful. The separated segment remained embedded to the vessel wall. A clinically significant delay was reported in the procedure and hospitalization was prolonged. The patient expired the next day due to heart failure. 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 Key10649560
MDR Text Key210424527
Report Number2024168-2020-08382
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number00529G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2020
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: 10/08/2020 Patient Sequence Number: 1
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