MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AHDC AGB KIT: 2-L 14 FR X 15 CM; CATHETER, HEMODIALYSIS, TRIPLE

Catalog Number	CDC-22142-XCN1A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "wire broke during dialysis catheter placement resulting in the patient requiring a second procedure.Procedure note: 1st attempt complicated by shearing and separation of overlying guidewire springs at catheter mid-point.Both pieces of the wire were retrieved from the patient successfully.2nd attempt used completely new line kit and line placed without difficulty.Patient notified of procedural/equipment complication immediately afterwards.Post-procedure cxr confirmed no retained wire products." the patient was reported as fine.
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: "wire broke during dialysis catheter placement resulting in the patient requiring a second procedure.Procedure note: 1st attempt complicated by shearing and separation of overlying guidewire springs at catheter mid-point.Both pieces of the wire were retrieved from the patient successfully.2nd attempt used completely new line kit and line placed without difficulty.Patient notified of procedural/equipment complication immediately afterwards.Post-procedure cxr confirmed no retained wire products." the patient was reported as fine.

• Brand Name: AHDC AGB KIT: 2-L 14 FR X 15 CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE
• 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: 19687366
• Report Number: 9680794-2024-00654
• Device Sequence Number: 7155835
• Product Code: NIE
• UDI-Device Identifier: 10801902213539
• UDI-Public: (01)10801902213539(11)230801(17)250414(10)33F23G0587(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143102
• 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): 06/10/2024

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: 04/14/2025
• Device Catalogue Number: CDC-22142-XCN1A
• Device Lot Number: 33F23G0587
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 Sex: Unknown