MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; CATHETER, PERCUTANEOUS

Catalog Number	UM-04018
Medical Device Problem Codes	Material Frayed (1262); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "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 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.It was repor ted "there was no patient harm, the patient has been safely discharged.".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of guidewire and needle resistance - guidewire separation cannot be confirmed as the photo only revealed the lidstock information.The device was not pictured in the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the complaint cannot be confirmed based on the customer photo as the photo only revealed the lidstock information.The device is not pictured in the photo.Additionally, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported via medwatch: "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 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.It was reported "there was no patient harm, the patient has been safely discharged.".

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20440509
• Report Number: 9680794-2024-01011
• Device Sequence Number: 20918483
• Product Code: DQY
• UDI-Device Identifier: 10801902118889
• UDI-Public: (01)10801902118889(11)231114(17)260228(10)33F23K0732(21)
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: UM-04018
• Device Lot Number: 33F23K0732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: Asian