MAUDE Adverse Event Report: ARROW EXT DWELL CATH DEVICE 22GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00622

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Tip of endurance catheter was dislodged when trying to remove the endurance from the patient.Tip was dislodged in patient's subcutaneous tissue.A one centimeter incision was made and the tip of the catheter was removed without any complication.Procedure performed by a physician in the er.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Tip of endurance catheter was dislodged when trying to remove the endurance from the patient.Tip was dislodged in patient's subcutaneous tissue.A one centimeter incision was made and the tip of the catheter was removed without any complication.Procedure performed by a physician in the er.

• Brand Name: ARROW EXT DWELL CATH DEVICE 22GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12478819
• MDR Text Key: 271685113
• Report Number: 9680794-2021-00462
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDC-00622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention