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

Catalog Number CS70097

Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (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.

• Brand Name: ARROW INTRA-AORTIC BALLOON CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 8273157
• MDR Text Key: 133958710
• Report Number: 8273157
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS70097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Date Report to Manufacturer: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA