MAUDE Adverse Event Report: ABBOTT ABBOTT; ARMADA 14 PTA CATHETER 4.0 MM X 120 MM X 150

Model Number A2040-120

Device Problems Retraction Problem (1536); Wire(s), breakage of (2347); Device Issue (2379)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 05/16/2018

Event Type  Injury  

Event Description

Patient had an ultrasound guided access left lower extremity popliteal vein balloon angioplasty.A retained 014 balloon tip and retained wire noted in left femoral vein; this occurred due to inability to remove balloon with deflation and other deflating maneuvers; wire sheared at popliteal access most likely due to multiple attempts to advance sheath over the wire to attempt new access and remove/snare 014 wire.

• Brand Name: ABBOTT
• Type of Device: ARMADA 14 PTA CATHETER 4.0 MM X 120 MM X 150
• Manufacturer (Section D): ABBOTT; abbott park IL
• MDR Report Key: 7615113
• MDR Text Key: 111814845
• Report Number: 7615113
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 8717648156168
• UDI-Public: (01)8717648156168
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018,05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: A2040-120
• Device Catalogue Number: A2040-120
• Device Lot Number: 7121241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2018
• Distributor Facility Aware Date: 05/16/2018
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2018
• 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: 32 YR
• Patient Weight: 114