MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN055871
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the guidewire does not fully advance, but the sheath, picc, and buddy wire all advance and the catheter was placed.Resistance was noted when inserting the wire.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one spring wire guide (swg) in its advancer for evaluation.The guide wire straightener and cap was not returned.There was one kink towards the distal end of the guide wire.Signs of use were observed on the guide wire and its advancer.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 399mm from the proximal tip of the guide wire.The guide wire length measured 45cm, which is within the specification limits of 43.75cm-46.26cm per the guide wire product drawing.The guide wire outer diameter measured 0.0178", which is within the specification limits of 0.0160"-0.0185" per the guide wire product drawing.The returned guide wire was inserted through a laboratory inventory 21ga introducer needle assembly using a laboratory inventory advancer.The guide wire was able to pass with little to no difficulty.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".A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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 report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one kink towards the distal end of the guide wire body.The guide wire met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on correspondence with the customer that resistance was observed during use and the sample received , unintentional use error likely 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 the guidewire does not fully advance, but the sheath, picc, and buddy wire all advance and the catheter was placed.Resistance was noted when inserting the wire.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS
• 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: 16853317
• Report Number: 9680794-2023-00348
• Device Sequence Number: 12671827
• Product Code: LJS
• UDI-Device Identifier: 10801902159967
• UDI-Public: 10801902159967
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Model Number: IPN055871
• Device Catalogue Number: ASK-45552-RH
• Device Lot Number: 13F22K1085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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; NOT REPORTED
• Patient Sex: Unknown