MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT: 20 GA. X 5"; CATHETER, PERCUTANEOUS

Model Number	IPN920537
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient was brought to interventional radiology (ir) for fistulogram with possible intervention.However, there was an issue with the arterial line before the patient went down and the radial arterial line was retained in the patient after removal.The fistulogram was put on hold until the arterial line issue was resolved.A radial artery thrombectomy was performed and the catheter was removed fully intact with brisk bleeding post thrombectomy.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheter for analysis.Signs of use in the form of adhesive residue were observed on the extension line.The separated portion of the catheter body was not returned for analysis.Visual analysis revealed that the catheter body was separated from the juncture hub.After performing dimensional and functional testing, the hub was cross sectioned to analyze the inner canal of the juncture hub.No portion of the catheter body was observed inside the juncture hub.The inner diameter of the juncture hub measured 1.0414mm, which is consistent with the catheter body outer diameter specifications of 1.040mm-1.090mm per the catheter product drawing.Dimensional analysis could not be performed on the separated catheter component as it was not returned for analysis.A lab inventory syringe filled with water was attached to the catheter luer hub.Water was observed exiting out of the distal hole in the juncture hub.Performed per ifu statement "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with peripheral intravascular devices must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury".The ifu provided with the kit informs the user, "do not use scissors to remove dressing to reduce the risk of cutting the catheter".The ifu also states, "do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters".The report of a separated arterial catheter was confirmed through complaint investigation.Visual analysis revealed that the catheter body became completely separated from the juncture hub.Additional analysis revealed that no portion of the catheter body was still molded within the juncture hub.Aside from this, the catheter met all relevant dimensional and functional requirements.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Patient was brought to interventional radiology (ir) for fistulogram with possible intervention.However, there was an issue with the arterial line before the patient went down and the radial arterial line was retained in the patient after removal.The fistulogram was put on hold until the arterial line issue was resolved.A radial artery thrombectomy was performed and the catheter was removed fully intact with brisk bleeding post thrombectomy.The patient's condition was reported to be fine.

• Brand Name: ARROW ARTERIAL LINE KIT: 20 GA. X 5"
• 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: 14569499
• Report Number: 9680794-2022-00348
• Device Sequence Number: 12205971
• Product Code: DQY
• UDI-Device Identifier: 10801902193916
• UDI-Public: 10801902193916
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN920537
• Device Catalogue Number: ASK-00820-CL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown