MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35; PTA CATHETER

Model Number REF B1120-060

Device Problem Failure to Advance (2524)

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

Event Date 12/24/2014

Event Type  malfunction  

Event Description

Prior to inserting in pt, staff unable to advance wire in catheter, never reached pt.

• Brand Name: ARMADA 35
• Type of Device: PTA CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 4398671
• MDR Text Key: 5301727
• Report Number: MW5040053
• 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: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: REF B1120-060
• Device Lot Number: 31023G1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 128