MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT ARMADA 35 7.0X40 MM BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Lot Number 11206G1

Device Problem Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

A 7 x 40 balloon was placed into right iliac artery to open up stenosis, and when the balloon was inflated it ruptured.The surgeon then had to make a larger opening to be able to remove the remains of the balloon.They were unable to use a closure device due to the size of the opening.They then held pressure for 20 mins then placed a dressing on the access site and took the patient to recovery.Once in recovery the patient began to bleed more and was taken back to the operating room.They were able to hold pressure for additional time to get the bleeding to stop and did not have to do a cut down.The patient was then taken back to recovery.Fda safety report id # (b)(4).

• Brand Name: ABBOTT ARMADA 35 7.0X40 MM BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 14074599
• MDR Text Key: 289092293
• Report Number: MW5108874
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 11206G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White