MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW OUS PI PICC KIT: 1-L 4.5FR X 50CM CG+; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN914728
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after implantation, at the follow-up x-ray, there was a presence in the lung that resulted from the x-ray.It was decided to retrieve the foreign body, which turned out to be the guide wire sheath that was located in the pulmonary artery.The patient is fine and the picc was left in situ.".It was reported the foreign body was retrieved by vascular surgery and "a catheter with a loop at the tip was introduced, and under radiographic control the foreign body was completely removed".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported that "after implantation, at the follow-up x-ray, there was a presence in the lung that resulted from the x-ray.It was decided to retrieve the foreign body, which turned out to be the guide wire sheath that was located in the pulmonary artery.The patient is fine and the picc was left in situ.".It was reported the foreign body was retrieved by vascular surgery and "a catheter with a loop at the tip was introduced, and under radiographic control the foreign body was completely removed".

• Brand Name: ARROW OUS PI PICC KIT: 1-L 4.5FR X 50CM CG+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 15107665
• Report Number: 9680794-2022-00457
• Device Sequence Number: 4214093
• Product Code: LJS
• UDI-Device Identifier: 10801902157543
• UDI-Public: 10801902157543
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN914728
• Device Catalogue Number: CDA-45041-HPK1A
• Device Lot Number: 13F21H0557
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown