MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ENDURANCE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	IPN037864
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly female in-patient (emergency-to-inpatient) for possible cardiovascular (cv) disease.During insertion of in-swelling iv the rn noted some resistance when she tried to advance the catheter.When she pulled the catheter out it appeared to be shortened and broken off.Radiologist notified and x-ray of left forearm taken.Allegedly a 17mm piece of catheter retained in soft tissue.Patient has subsequently been discharged.

• Brand Name: ARROW ENDURANCE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill boulevard; morrisville NC 27560
• MDR Report Key: 16136873
• Report Number: 16136873
• Device Sequence Number: 17821981
• Product Code: FOZ
• UDI-Device Identifier: 10801902133004
• UDI-Public: 10801902133004
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/03/2023
• Report Date (Section F): 01/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN037864
• Device Catalogue Number: EDC-00620-B
• Device Lot Number: 13F22K0354
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White
• Date Report Sent to FDA: 01/03/2023