MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-47702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the swg was kinked due to the swg soft during use on the patient." the operator changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned a guide wire and catheter for evaluation.Some signs of use were observed.The guide wire was observed to have a kink in the middle of the body and slight bends throughout the remaining body.The distal j-bend was intact.Microscopic examination confirmed the kink in the guide wire body.Both distal and proximal welds were present and were observed to be full and spherical.Kinks on the guide wire were measured at 181mm, 263mm, and 374mm from the proximal end.Slight bends were measured at 34mm, 435mm, and 496mm from the proximal end.The guide wire length measured 601mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.791mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Existing lab inventory was used to complete functional testing.The guide wire was advanced through an arrow syringe and 18ga needle.The distal end of the guide wire passed with little to no difficulty; however , significant resistance was encountered at the locations of the kinks.Performed per ifu statement "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through visual analysis of the returned sample.The guide wire was kinked at one location near the middle of the body, along with bends throughout.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the swg was kinked due to the swg soft during use on the patient." the operator changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine.".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20696276
• Report Number: 3006425876-2024-01098
• Device Sequence Number: 3783177
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)240326(17)251108(10)71F24C0966(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 11/08/2025
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F24C0966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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 Sex: Unknown