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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/08/2018

Event Type  Injury  

Event Description

Pt underwent a heart catheterization and pci and was found to have severe disease in the lad, pci to the mid lad w/ des and pci to the proximal lad w/ des.As the ptca balloon was being removed, it was noted that the shaft of the nc ptca balloon unraveled and broke.Attempts to telescope and snare the ptca balloon were unsuccessful.Ultimately, a trek ptca balloon, advanced on a coronary guidewire, was successful in retrieval of the retained ptca balloon.Pt was discharged to home on (b)(6) 2018.

• Brand Name: NC TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 8115280
• MDR Text Key: 128878234
• Report Number: MW5081680
• Device Sequence Number: 0
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 116