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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-15
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents reported from this lot. In this case, the device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use. It should be noted that the instructions for use (ifu), for the trek rx and mini trek rx, states: balloon pressure should not exceed the rated burst pressure (rbp). Use of a pressure-monitoring device is recommended to prevent over-pressurization. In this case, the reported ifu violation does not appear to have caused or contributed to the reported complaint. The investigation determined the reported difficulty to advance and balloon rupture appears to be related to operational circumstances of the procedure. In this case, based on the reported information, it is likely that during advancement and/or inflation, the balloon outer surface became compromised and/or damaged against the heavily calcified, mildly tortuous, 90% stenosed anatomy resulting in the balloon rupture. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, mildly tortuous, 90% stenosed right coronary artery. A 2x15mm mini trek balloon dilatation catheter (bdc) was advanced with resistance with the anatomy. During the first inflation, the balloon ruptured at 16 atmospheres. An unspecified balloon and stent were used to successfully complete the procedure. 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 RX 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 Key10706165
MDR Text Key212139260
Report Number2024168-2020-08731
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-15
Device Catalogue Number1012270-15
Device Lot Number00506G1
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 Received09/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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