MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15802-E
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "swg was hard to advance.Wire was kinked when it was removed.There wa sno reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The customer returned the tubing from a guide wire assembly and one arrow raulerson syringe (ars) for analysis.The actual guide wire was not returned.No obvious signs of use were observed.Visual analysis did not reveal any defects or anomalies with the returned samples.Visual analysis of the guide wire could not be performed without being returned for analysis.The returned ars was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." a lab inventory 0.826 mm guide wire was advanced through the returned ars and was able to advance through with little to no resistance.Functional inspection of the guide wire could not be performed without the guide wire returned.The ifu provided with this kit informs the user, "advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion." the customer report of guide wire difficult to advance was not confirmed by complaint investigation of the returned sample.The guide wire was not returned.The returned ars met all relevant functional requirements with a lab inventory guide wire.Without the guide wire 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: CVC SET: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19960076
• Report Number: 3006425876-2024-00820
• Device Sequence Number: 12528941
• Product Code: DQY
• UDI-Device Identifier: 40801902127745
• UDI-Public: (01)40801902127745(11)230202(17)280131(10)71F23A2139(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 08/02/2024

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 Catalogue Number: CS-15802-E
• Device Lot Number: 71F23A2139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Patient Sex: Unknown