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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012268-06
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product performance engineering reviewed the incident information; however, 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 mini trek rx, global, instructions for use states: slide the protective sheath off the balloon. Note: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating. In this case, the reported ifu violation does not appear to have caused or contributed to the reported balloon rupture. The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure. In this case, it is likely that during inflation the balloon became compromised and/or damaged against the 99% stenoses anatomy resulting in the balloon rupture at 12 atmospheres. There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
 
Event Description
It was reported that the procedure was performed to treat a lesion with 99% stenosis in the right coronary artery. Prior to use, a 1. 20 x 6mm mini trek balloon dilatation catheter (bdc) was not soaked in saline. While pre-dilatation was being performed, the balloon of the bdc ruptured during first inflation at 12 atmospheres. The bdc was simply removed and another same size trek bdc was used to successfully complete the procedure. There were no reported adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMINI TREK 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 Key10744499
MDR Text Key213692413
Report Number2024168-2020-08953
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 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012268-06
Device Lot Number91104G1
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
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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