MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVB
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported when the inserter went to thread guidewire, the wire threaded through the needle and vessel without resistance.When the inserter pulled back to remove wire, the wire was stuck and would not remove easily.The wire and needle were removed together ,and another kit was used.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one nitinol straight guide wire for analysis.The needle was not returned.Signs of use were observed on the guide wire.Visual analysis revealed that there was one kink with offset coils, and one bend on the distal end of the guide wire.The distal weld appeared full and spherical as well as intact.Visual analysis of the needle could not be performed as it was not returned.The kink in the guide wire measured 47mm from the distal tip.The bend in the guide wire measured approximately 33mm from the distal tip.The overall length of the guide wire measured 45.1cm which is within the specification of 43.75-46.25cm per guide wire product drawing.The outer diameter of the guide wire measured 0.01780" which is within the specification of 0.0160"-0.0185" per guide wire product drawing.Dimensional analysis of the needle could not be performed as it was not returned.Functional testing was performed per ifu statement, "raise thumb and pull arrow advancer approximately 4 - 8 cm away from introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into needle to further advance guidewire.Continue until guidewire reaches desired depth." the guide wire was advanced through a laboratory ars/21ga introducer needle assembly and was able to pass through with little to no resistance.A manual tug test confirmed the distal weld was 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 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." the customer report of a kinked guide wire was confirmed through examination of the returned sample.Visual examination revealed one kink and one bend at the distal end.The introducer needle was not returned.The guide wire met all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.Based on these circumstances and the customer description, the root cause could not be determined as the introducer needle was not returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported when the inserter went to thread guidewire, the wire threaded through the needle and vessel without resistance.When the inserter pulled back to remove wire, the wire was stuck and would not remove easily.The wire and needle were removed together , and another kit was used.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 17506105
• Report Number: 9680794-2023-00611
• Device Sequence Number: 6580634
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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?: Yes
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 13F22L0948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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