MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with the needle and wire in the arterial kit.Additional information from the clinical staff indicated that pulsatile blood flow was observed upon needle insertion; and resistance was encountered when inserting the wire.An attempt was made to retract the wire to check blood flow, but the wire would not retract.As a result, both the needle and wire were removed together.The bevel was up during wire insertion, and the wire was removed intact but bent.There was no harm or consequences to the patient, and no medical intervention was required.The patient later passed away, and the death was unrelated to this incident.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The device was not returned; however, the customer provided one photo for evaluation.The complaint of guide wire and needle resistance resulting in a kinked guide wire was able to be confirmed by the photo as it revealed a guide wire protruding out of the needle cannula with a kink near the distal j-bend.A complete visual inspection to evaluate the cause of the damage 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 spring-wire guide damage, do not retract spring wire guide against edge of needle while in vessel.Caution: use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide." the complaint of kinked guide wire was able to be confirmed by the photo as it revealed a guide wire protruding out of the needle cannula with a kink near the distal j-bend.Full complaint verification testing to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Additional information provided from the customer indicated that when they experienced resistance, they retracted the guide wire while it was within the needle cannula.The instructions for use provided with this kit states, "warning: to reduce the risk of spring-wire guide damage, do not retract spring wire guide against edge of needle while in vessel.If resistance is encountered, remove spring-wire guide and catheter together as a unit.".However, 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 that there was an issue with the needle and wire in the arterial kit.Additional information from the clinical staff indicated that pulsatile blood flow was observed upon needle insertion; and resistance was encountered when inserting the wire.An attempt was made to retract the wire to check blood flow, but the wire would not retract.As a result, both the needle and wire were removed together.The bevel was up during wire insertion, and the wire was removed intact but bent.There was no harm or consequences to the patient, and no medical intervention was required.The patient later passed away, and the death was unrelated to this incident.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 21265041
• Report Number: 9680794-2025-00081
• Device Sequence Number: 15821525
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)230227(17)280131(10)33F23B0953(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2025

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 Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F23B0953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown