MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH. SET: 22 GA X 5CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00522-PBX

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported "an arterial line is installed in the patient, the guidewire is inserted into the needle, but it gets stuck.The arterial line and the guidewire are retired.A fragment of the guidewire is seen into the needle and the rest is disassembled." no patient harm was reported.The device was replaced with another arterial line.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer report of swg unraveled was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not alter the catheter, guidewire, or any other kit/set component during insertion, use or removal.Warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." 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 Description

It was reported "an arterial line is installed in the patient, the guidewire is inserted into the needle, but it gets stuck.The arterial line and the guidewire are retired.A fragment of the guidewire is seen into the needle and the rest is disassembled." no patient harm was reported.The device was replaced with another arterial line.The patient's condition is reported as fine.

• Brand Name: ARROW ARTERIAL CATH. SET: 22 GA X 5CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17058875
• MDR Text Key: 317068884
• Report Number: 3006425876-2023-00538
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K171146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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 Catalogue Number: SAC-00522-PBX
• Device Lot Number: 71F22C1590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 57 YR