MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Lot Number 13F21H1316

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Separation Problem (4043)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Picc line was being placed in pt left cephalic vein.Vein access was uneventful, but when threading the picc through the sheath, the handles on the sheath came off of the sheath that was in the vein.Therefore the 7 cm sheath was inside the patient's vein and there was no way to remove the sheath.Attempted removal by interventional radiology (ir) nurse practitioner and also ir doctor but unable to do so.Vascular surgeon was called and will take patient to or to remove.

• Brand Name: ARROW
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13017775
• MDR Text Key: 282329876
• Report Number: 13017775
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021,11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 13F21H1316
• 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: 11/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1