MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR TREK BALLOON DILATATION CATHETER; CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS

Model Number 1012274-20

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

Event Description

Angioplasty balloon burst, fragment remained in coronary artery.No harm to patient.

• Brand Name: ABBOTT VASCULAR TREK BALLOON DILATATION CATHETER
• Type of Device: CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 7717771
• MDR Text Key: 115099751
• Report Number: MW5078565
• Device Sequence Number: 1
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Was Device Available for Evaluation?: No
• 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: 84 YR
• Patient Weight: 84