MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number	IPN920375
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch received reports: "on [redacted date], the patient underwent coronary brachytherapy via right femoral arterial access.Later that same day while the provider was attempting to gently remove the femoral access catheter with minimal traction, the head of the catheter and side port fractured off with the catheter shaft still remaining in situ and a rush of brisk arterial blood followed.The provider immediately applied and maintained manual pressure proximally to the arteriotomy site against the femoral head, with he mostasis was achieved.Vascular surgery was stat paged to the patient's bedside as provider continued to hold manual pressure throughout the entire time.The patient was then taken emergently to the or for exploration and removal of retained access catheter.The specific introducer used was a "set introducer super arrow-flex 7fr 11cm hemostatic valve percutaneous sheath integral side port attached 3way stopcock radiopaque tip orange cs/10ea".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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
Medwatch received reports: "on [redacted date], the patient underwent coronary brachytherapy via right femoral arterial access.Later that same day while the provider was attempting to gently remove the femoral access catheter with minimal traction, the head of the catheter and side port fractured off with the catheter shaft still remaining in situ and a rush of brisk arterial blood followed.The provider immediately applied and maintained manual pressure proximally to the arteriotomy site against the femoral head, with he mostasis was achieved.Vascular surgery was stat paged to the patient's bedside as provider continued to hold manual pressure throughout the entire time.The patient was then taken emergently to the or for exploration and removal of retained access catheter.The specific introducer used was a "set introducer super arrow-flex 7fr 11cm hemostatic valve percutaneous sheath integral side port attached 3way stopcock radiopaque tip orange cs/10ea".

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 16898797
• Report Number: 9680794-2023-00332
• Device Sequence Number: 5459250
• Product Code: DQY
• UDI-Device Identifier: 10801902194173
• UDI-Public: 10801902194173
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: IPN920375
• Device Catalogue Number: CP-07711
• Device Lot Number: 14F22E
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic