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

Model Number 1012453-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969)

Event Date 07/10/2021

Event Type  malfunction  

Event Description

Patient admitted with cp x few weeks and found to have st-elevated myocardial infarction stemi.The patient was taken to the catheterization lab for angiography and potential percutaneous intervention.During the procedure, coronary balloon, from nc trek coronary dilatation catheter, could not be removed from guide catheter during angioplasty/stent procedure.The body of the balloon telescoped inside itself and made a hard ridge that got stuck on guideliner making it impossible to be removed from guide catheter.As a result, the entire system had to be removed.Additional notes.Drug-eluting stent placed and post-dilated with a 4.0 x 15 mm nc trek balloon at high pressure.Health care providers were unable to pull the deflated balloon completely back into the guide, so the entire system was removed as one.The balloon then stuck as it was entering the radial sheath.The balloon was advanced over the wire a bit, inflated to very low pressure, and then successfully withdrawn as it was deflated.Inspection of the balloon revealed that the more distal edge that had failed to assume a lower profile.

• Brand Name: NC TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 12216846
• MDR Text Key: 263138253
• Report Number: 12216846
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 10213G1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 96