MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN033929
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Medwatch report received: "during catheter insertion, the guidewire split as it was being removed.All parts of the guidewire were removed.Information sent to central service to track occurrences.From post-procedure note: the vein was cannulated with a finder needle.Immediately upon entering the vein dark, non-pulsatile blood did return.Ultrasound was used to confirm venous pressures.Subsequently the wire was fed through the needle and the needle was then removed.A small skin incision was made at the puncture site to allow the dilator to be inserted.After dilation, the catheter was then placed over the guidewire.To this point everything went well.The guidewire was attempted to be removed from the placed catheter but became stuck within the catheter.The entire catheter and guidewire were removed.The procedure was attempted again as above, and the catheter was successfully placed, and the guidewire completely removed.The catheter was sutured in place and a sterile dressing was applied over the site.".
Event or Problem Description
Medwatch report received: during catheter insertion, the guidewire split as it was being removed.All parts of the guidewire were removed.Information sent to central service to track occurrences.From post-procedure note: the vein was cannulated with a finder needle.Immediately upon entering the vein dark, non-pulsatile blood did return.Ultrasound was used to confirm venous pressures.Subsequently the wire was fed through the needle and the needle was then removed.A small skin incision was made at the puncture site to allow the dilator to be inserted.After dilation, the catheter was then placed over the guidewire.To this point everything went well.The guidewire was attempted to be removed from the placed catheter but became stuck within the catheter.The entire catheter and guidewire were removed.The procedure was attempted again as above, and the catheter was successfully placed, and the guidewire completely removed.The catheter was sutured in place and a sterile dressing was applied over the site.
Additional Manufacturer Narrative
(b)(4), 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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 15831617
• Report Number: 9680794-2022-00726
• Device Sequence Number: 5044324
• Product Code: FOZ
• UDI-Device Identifier: 10801902005820
• UDI-Public: 10801902005820
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Expiration Date: 10/31/2024
• Device Model Number: IPN033929
• Device Catalogue Number: AK-15123-F
• Device Lot Number: 13F22D0285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/20/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Race: White