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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ABBOTT VASCULAR INC. NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 1012451-15
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
Fracture and distal migration of nc balloon into the high diagonal branch. Retained shaft of balloon catheter in the aortoiliac system. Patient brought to procedure room; prepped and draped in sterile fashion. Time out performed. Excerpts from procedural note: noncompliant balloon was prepped, loaded and advanced over the coronary run-through wire. There was some resistance to balloon advancement through the guide catheter, visualized under fluoroscopy. It was noted that the balloon did not respond to catheter movement and appeared to be stuck in the proximal part of the vessel. On attempting to withdraw the catheter, we realized that the shaft of the catheter had fractured resulting a retained segment in the aorta with the balloon trapped in the high diagonal branch. A second pt graphix coronary guide wire was advanced inside the guide catheter over which a compliant balloon was advanced and inflated inside the guide catheter. The balloon was left inflated trapping the shaft and the guide catheter was withdrawn. At this time, we noted that the balloon at the tip of the catheter had also fractured off and trapped within the high diagonal branch. The rest of the shaft of the balloon catheter was noted to be lodged in the aortic arch extending down into the right common iliac artery. Multiple attempts were made to snare balloon shaft but were unsuccessful, despite calling in a interventional cardiologist. Successful externalization of the retained non-compliant balloon fragment in the mid first diagonal branch was done by deploying a single drug-eluting stent with resulting timi-3 flow in the distal vessel. An interventional radiologist was called in to help. He attempted to snare the catheter from right femoral approach but was unsuccessful. Due to the prolonged procedural and fluoroscopy time, we decided to abandon any further attempt at retrieval today and bring him back tomorrow and attempt retrieval again. Addendum by interventional cardiology fellow the following day: patient underwent successful retrieval of balloon shaft fragments via right femoral approach in interventional radiologist. It was noted that the balloon was still intact on the balloon catheter and it was, in fact, the radiopaque marker that had stripped off the balloon and had embolized into the coronary artery. Hemostasis was achieved at the end of the procedure.
 
Event Description
Fracture and distal migration of nc balloon into the high diagonal branch. Retained shaft of balloon catheter in the aortoiliac system. Patient brought to procedure room; prepped and draped in sterile fashion. Time out performed. Excerpts from procedural note: noncompliant balloon was prepped, loaded and advanced over the coronary run-through wire. There was some resistance to balloon advancement through the guide catheter, visualized under fluoroscopy. It was noted that the balloon did not respond to catheter movement and appeared to be stuck in the proximal part of the vessel. On attempting to withdraw the catheter, we realized that the shaft of the catheter had fractured resulting a retained segment in the aorta with the balloon trapped in the high diagonal branch. A second pt graphix coronary guide wire was advanced inside the guide catheter over which a compliant balloon was advanced and inflated inside the guide catheter. The balloon was left inflated trapping the shaft and the guide catheter was withdrawn. At this time, we noted that the balloon at the tip of the catheter had also fractured off and trapped within the high diagonal branch. The rest of the shaft of the balloon catheter was noted to be lodged in the aortic arch extending down into the right common iliac artery. Multiple attempts were made to snare balloon shaft but were unsuccessful, despite calling in a interventional cardiologist. Successful externalization of the retained non-compliant balloon fragment in the mid first diagonal branch was done by deploying a single drug-eluting stent with resulting timi-3 flow in the distal vessel. An interventional radiologist was called in to help. He attempted to snare the catheter from right femoral approach but was unsuccessful. Due to the prolonged procedural and fluoroscopy time, we decided to abandon any further attempt at retrieval today and bring him back tomorrow and attempt retrieval again. Addendum by interventional cardiology fellow the following day: patient underwent successful retrieval of balloon shaft fragments via right femoral approach in interventional radiologist. It was noted that the balloon was still intact on the balloon catheter and it was, in fact, the radiopaque marker that had stripped off the balloon and had embolized into the coronary artery. Hemostasis was achieved at the end of the procedure.
 
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Brand NameNC TREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez road
temecula CA 92591
MDR Report Key13598604
MDR Text Key286119074
Report Number13598604
Device Sequence Number1
Product Code LOX
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 02/18/2022,02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012451-15
Device Catalogue Number1012451-15
Device Lot Number10812G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2022
Event Location Hospital
Date Report to Manufacturer02/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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