MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BD POWERPICC SOLO 2 5FR TRIPLE LUMEN (WIRE); CATHETER, INTRAVASCULAR, THERAPEUTIC LONG-TERM GREATER THAN 30 DAYS

Catalog Number 3395335Q

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Date 02/14/2020

Event Type  Death  

Event Description

Retained wire discovered on post-procedure x-ray inside pt's right ventricle.Fda safety report id# (b)(4).

• Brand Name: BD POWERPICC SOLO 2 5FR TRIPLE LUMEN (WIRE)
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 9763520
• MDR Text Key: 181337843
• Report Number: MW5093307
• Device Sequence Number: 1
• Product Code: LJS
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 3395335Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Death; Disability
• Patient Age: 360 YR