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

Model Number IPN033929

Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

During catheter insertion, the guidewire split as it was being removed.All parts of the guidewire were removed.Information sent to central service to track occurrences.From post-procedure note: the vein was cannulated with a finder needle.Immediately upon entering the vein dark, non-pulsatile blood did return.Ultrasound was used to confirm venous pressures.Subsequently the wire was fed through the needle and the needle was then removed.A small skin incision was made at the puncture site to allow the dilator to be inserted.After dilation, the catheter was then placed over the guidewire.To this point everything went well.The guidewire was attempted to be removed from the placed catheter but became stuck within the catheter.The entire catheter and guidewire were removed.The procedure was attempted again as above, and the catheter was successfully placed, and the guidewire completely removed.The catheter was sutured in place and a sterile dressing was applied over the site.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15690309
• MDR Text Key: 302586900
• Report Number: 15690309
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/13/2022

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 Model Number: IPN033929
• Device Catalogue Number: AK-15123-F
• Device Lot Number: 13F22D0285
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Race: White