MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Model Number	IPN919963
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " hemodialysis catheter inserted under ultrasound guidance into the right femoral vein.During cannulation, they use a introducer needle.Insert swg after syringe disconnection.The catheter is placed along the swg.As the swg is removed through the catheter.There is resistance.The swg was pulled out with force.The end of the guide takes the shape of a "pig's tail", a "coiled spring".
Event or Problem Description
It was reported that " hemodialysis catheter inserted under ultrasound guidance into the right femoral vein.During cannulation, they use a introducer needle.Insert swg after syringe disconnection.The catheter is placed along the swg.As the swg is removed through the catheter.There is resistance.The swg was pulled out with force.The end of the guide takes the shape of a "pig's tail", a "coiled spring".Associated complaints 3006425876-2023-01207.3006425876-2023-01206.3006425876-2023-01205.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer provided photos for analysis, but the complaint of a damaged guide wire could not be confirmed through the images.The instructions for use (ifu) provided with this kit warns the user, "precaution: if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel." 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " hemodialysis catheter inserted under ultrasound guidance into the right femoral vein.During cannulation, they use a introducer needle.Insert swg after syringe disconnection.The catheter is placed along the swg.As the swg is removed through the catheter.There is resistance.The swg was pulled out with force.The end of the guide takes the shape of a "pig's tail", a "coiled spring".Associated complaints: 3006425876-2023-01207, 3006425876-2023-01206, 3006425876-2023-01205.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18289951
• Report Number: 3006425876-2023-01206
• Device Sequence Number: 20310819
• Product Code: DQY
• UDI-Device Identifier: 10801902096583
• UDI-Public: (01)10801902096583(11)230223(17)250113(10)71F23F0936(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: IPN919963
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F23F0936
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 03/22/2024; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/26/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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; NOT REPORTED
• Patient Sex: Male