MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT 3.0X30 TREK BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Device Problems Device Dislodged or Dislocated (2923); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2021

Event Type  Injury  

Event Description

When the device was being removed from the patient, it became stuck to an area of calcium in the patient's vessel, ultimately dislodging the balloon shaft becoming retained.Fda safety report id# (b)(4).

• Brand Name: ABBOTT 3.0X30 TREK BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 13111121
• MDR Text Key: 282989189
• Report Number: MW5106318
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic