MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR ARMADA 35 10.0MM X 20MM X 135CM OTW PTA; ARMADA PTA CATHETER

Catalog Number B2100-020

Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 05/21/2018

Event Type  Injury  

Event Description

During angioplasty within existing fractured stents the balloon ruptured and due to difficulty removing, it was removed along with the wire and the sheath as a unit.The balloon tip was unaccounted for.

• Brand Name: ABBOTT VASCULAR ARMADA 35 10.0MM X 20MM X 135CM OTW PTA
• Type of Device: ARMADA PTA CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 7641154
• MDR Text Key: 112583781
• Report Number: MW5078087
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: B2100-020
• Device Lot Number: 70714G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR