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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW INTRA-AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX INCORPORATED ARROW INTRA-AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number CS70097
Device Problems Defective Device (2588); Activation, Positioning or SeparationProblem (2906)
Patient Problems Occlusion (1984); Ventricular Fibrillation (2130); Stenosis (2263)
Event Date 12/18/2018
Event Type  malfunction  
Event Description
The first iabp (intra-aortic balloon pump) catheter inserted during procedure was defected. When removed found balloon not intact. In summary, this cardiac catheterization shows: ejection fraction severely decreased. Probably acute occlusion of the right coronary artery that caused the ventricular fibrillation at another facility, emergency intervention will be advised. At this point, pt was started in advance of the totally occluded right coronary artery. We used a #6 4 guide, it was certainly not in the right main artery and then we used an 0. 014 runthrough guidewire, was able to cross the total occlusion successfully and then we followed with a 2. 0 x 12 balloon and did 3 inflations at the area of the total occlusion. The balloon was removed and then we inserted a 24 x 2. 25 synergy stent deployed at the mid stenosis. There was some proximal stenosis close to the ostium. We inserted a 2. 25 x 12 synergy stent there and finally between the 2 stents, there was a gap and stenosis at the edge of the first stent, so we inserted a 2. 25 x 16 synergy stent and deployed it to cover the whole artery. Final injection was done which showed excellent dilation and patency with timi 3 flow. The stent placed was judged to be very successful.
 
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Brand NameARROW INTRA-AORTIC BALLOON CATHETER
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8273157
MDR Text Key133958710
Report Number8273157
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCS70097
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2019
Event Location No Information
Date Report to Manufacturer01/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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