MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918648
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: eptic without iodine (b)(4) associated mdrs: 3006425876-2023-00246.
Event or Problem Description
It was reported that "the dilator immediately expands, twists and does not even pass through the skin, and if it passes through the skin, it expands during tissue dilation, gets stuck when pulling out, damages the tissues.The guidewire also bends, it happened in practice that the dilator folded the guidewire and stuck".It was reported the "dilator end separated when already entered the skin and got stuck together with the guidewire".The insertion site was the subclavian vein.There was "no severe damage to the patient's health".It was reported "no severe tissue damaging, doctor indicated site bleeding, but another set was used to perform the procedure".The patient's condition is reported as fine.
Event or Problem Description
It was reported that "the dilator immediately expands, twists and does not even pass through the skin, and if it passes through the skin, it expands during tissue dilation, gets stuck when pulling out, damages the tissues.The guidewire also bends, it happened in practice that the dilator folded the guidewire and stuck".It was reported the "dilator end separated when already entered the skin and got stuck together with the guidewire".The insertion site was the subclavian vein.There was "no severe damage to the patient's health".It was reported "no severe tissue damaging, doctor indicated site bleeding, but another set was used to perform the procedure".The patient's condition is reported as fine.
Additional Manufacturer Narrative
Continuation of d11: eptic without iodine.Qn #(b)(4).Associated mdrs: 3006425876-2023-00271; 3006425876-2023-00246.The actual device was not returned; however, the customer provided four photos for analysis.The complaint of dilator tip damaged was able to be confirmed by one of the photos.The image shows a dilator with a deformed tip and evidence of use (dried blood).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, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.The customer report of dilator tip damaged was confirmed by visual inspection of the customer supplied photo.The image shows a dilator with a deformed tip and evidence of use (dried blood).However, full complaint verification testing could not be performed as no sample was returned for analysis.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.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16571906
• Report Number: 3006425876-2023-00271
• Device Sequence Number: 4925917
• Product Code: DQY
• UDI-Device Identifier: 10801902182187
• UDI-Public: 10801902182187
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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 Model Number: IPN918648
• Device Catalogue Number: CS-15853-E
• Device Lot Number: 71F22H2435
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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: OCTINESCEPT SKIN ANTISEPTIC AND COLORED SKIN ANTIS; OCTINESCEPT SKIN ANTISEPTIC AND COLORED SKIN ANTIS
• Patient Sex: Unknown