MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT 2-L: 5.5 FR X 50CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-45052-HPK1A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: provider tried to use the guidewire to place the line but was not able to get into the patients vein with the wire.Wire was bent at a 30degree angle when removed and there was a slight bump in the wire where the angle is.There was no reported patient harm or consequence.Another device was use successfully.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire within its advancer for evaluation.Signs of use were observed on the returned components.The guide wire was observed to have one kink and one bend towards the distal end of the body.Microscopic examination confirmed the kink in the guide wire body.The distal weld was present but did not appear spherical.The kink in the guide wire was located 40 mm from the distal tip while the bend was approximately 46 mm from the distal tip.The overall length of the guide wire measured 44.9 cm which is within the specification limits of 43.75-46.25 cm per guide wire product drawing.The outer diameter of the guide wire measured 0.01810" which is within the specification limits of 0.0160"-0.0185" per guide wire product drawing.The guide wire was advanced through a lab inventory ars and a lab inventory 21ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.Performed per the instructions-for-use (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." a manual tug test confirmed that the distal weld was intact.Manufacturing and r & d were contacted as a part of this complaint investigation.Manufacturing stated that there is a 100% inspection of the guide wires for kinks.R & d stated that the condition of the weld was acceptable as there was nothing protruding outside of the coil diameter to cause resistance.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had one kink and one bend towards the distal tip.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review based on a potential lot from sales history 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 that: provider tried to use the guidewire to place the line but was not able to get into the patients vein with the wire.Wire was bent at a 30degree angle when removed and there was a slight bump in the wire where the angle is.There was no reported patient harm or consequence.Another device was use successfully.

• Brand Name: ARROW PI AGBA PICC KIT 2-L: 5.5 FR X 50CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18378584
• Report Number: 9680794-2023-01012
• Device Sequence Number: 20775230
• Product Code: LJS
• UDI-Device Identifier: 50801902124055
• UDI-Public: 50801902124055
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/27/2023

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 Catalogue Number: CDC-45052-HPK1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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