MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA; 50MM X 80MM, X 135CM

Catalog Number B-2050-080

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2015

Event Type  malfunction  

Event Description

Armada balloon leaked.Injection port connecter site, to the balloon site.Removed balloon.Opened up new balloon.And performed angioplasty.

• Brand Name: ABBOTT VASCULAR ARMADA
• Type of Device: 50MM X 80MM, X 135CM
• MDR Report Key: 5327363
• MDR Text Key: 34437287
• Report Number: MW5058732
• Device Sequence Number: 1
• Product Code: LIT
• 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: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: B-2050-080
• Device Lot Number: 40814G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 36