MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ENDURANCE(TM) EXTENDED DWELL PERIPHERAL CATHETER SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2019

Event Type  malfunction  

Event Description

Picc nurse attempting to place arrow endurance catheter, and wire did not deploy.

• Brand Name: ARROW ENDURANCE(TM) EXTENDED DWELL PERIPHERAL CATHETER SYSTEM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville rd; reading PA 19605
• MDR Report Key: 8411493
• MDR Text Key: 138516547
• Report Number: 8411493
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1