MAUDE Adverse Event Report: PIGTAIL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2023

Event Type  Injury  

Event Description

During chest tube procedure, a pigtail catheter was placed just superior to the fifth rib at the right midaxillary line.The tube was sutured into place.Difficulty in release of introducer wire upon withdrawal of introducer and wire from catheter resulting in residual wire left in chest tube.Next day, chest tube removed as wire was no visible within the line hub to pull out.After pulling tube out the wire was evident leaving skin and this was pulled out.The distal tip was intact while the proximal (skin-side) wire was frayed.

• Brand Name: PIGTAIL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 17020311
• MDR Text Key: 316235459
• Report Number: MW5117971
• Device Sequence Number: 1
• Product Code: DQO
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White