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

Model Number	IPN920005
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While inserting a central venous catheter into right femoral site, i was also trying to insert an arterial line.After verifying that my introducer needle was in the femoral artery per us (ultrasound) plus clinical verification per pulsating blood return from the arterial needle, i inserted the guidewire thru the needle.The guide wire went in smoothly.However, when i was retracting the needle out, i encountered resistance.I manipulated the guidewire (moving it in and out to see if the resistance will disappear).The resistance improved; however, when i totally pulled out the needle, the guidewire "frayed".Since there was resistance, as if the tip of the guidewire is anchored inside the skin, i did not try any further attempt to recover the tip of the guidewire.Patient went to neuro ir where the patient underwent pipeline assisted coil embolization, also successful retrieval of the remnant of the guidewire from the right femoral site.There was no hematoma, no vascular compromise of the leg post-procedure.

• Brand Name: ARROW
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 20235897
• Report Number: 20235897
• Device Sequence Number: 20999364
• Product Code: DQY
• UDI-Device Identifier: 10801902192063
• UDI-Public: (01)10801902192063
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/30/2024
• Report Date (Section F): 05/30/2024

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: IPN920005
• Device Catalogue Number: UM-04018
• Device Lot Number: 33F23K0732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 05/30/2024