MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920475
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during a procedure, the catheter broke and was not functioning.The customer attempted to dissect and reinsert it, but it still did not work.This incident marks the third catheter that has broken in a similar manner.The catheter had a "kink" on its body; at first, it worked normally, but after about 24 hours, occlusions began to occur.No emergency treatment was required, except for the replacement of the given catheter.Pneumothorax was present bilaterally, but chest drainage was not required, and pneumothorax was "absorbed" spontaneously within 42 hours".
Event or Problem Description
It was reported "during a procedure, the catheter broke and was not functioning.The customer attempted to dissect and reinsert it, but it still did not work.This incident marks the third catheter that has broken in a similar manner.The catheter had a "kink" on its body; at first, it worked normally, but after about 24 hours, occlusions began to occur.No emergency treatment was required, except for the replacement of the given catheter.Pneumothorax was present bilaterally, but chest drainage was not required, and pneumothorax was "absorbed" spontaneously within 42 hours".Associated report# 9680794-2024-01225.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The first photo displayed an x-ray image of the catheter placed within the patient.The catheter contained one kink along the body.The second photo displayed the product lidstock.Therefore, the complaint of a kinked catheter was able to be confirmed by the first photo.A device history record review was performed and potentially relevant findings were identified.A non-conformance was created for material rv-21523-045a with batch 13c23l0209 regarding foreign material.Further review of the finding revealed that it was not relevant to the reported event.The instructions for use (ifu) provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 21006487
• Report Number: 9680794-2024-01224
• Device Sequence Number: 15156038
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)240528(17)270430(10)33F24C0059(21)
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K141051
• 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): 11/18/2024

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: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F24C0059
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 140 KG