MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45052-VPS2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire for evaluation.The introducer needle was not returned.No definite evidence of use was observed.Visual examination revealed the guide wire was unraveled from the distal weld.Slight bending of the distal end was observed.The distal j-bend was misshapen and intact.Microscopic examination of the guide wire confirmed the core wire was broken in the middle of the guide wire body.The proximal separation point was extruding out of the coil wire and the distal separation point remained within the coil wire.Visual inspection of the introducer needle could not be performed as the needle was not returned.The two pieces of the guide wire core wire added up to 45 cm, which is within the specifications of 44.5 - 45.5cm per guide wire product drawing.The outer diameter of the guide wire measured 0.0176" which is within the od specification of 0.0175 - 0.0180" per guide wire product drawing.Dimensional inspection of the introducer needle could not be performed as the needle was not returned.Functional inspection could not be performed due to the damage to the returned guide wire and without the needle returned for analysis.A device history record review was performed, and no relevant findings were identified.Instructions-for-use (ifu) provided with this product warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of an unraveled guide wire was confirmed through examination of the returned sample.The guide wire coil wire was unraveled in the middle of the body due to a separation of the core wire.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, the appearance of the damage is consistent with unintentional user error.However, without the reported needle returned for evaluation, the probable cause of the guide wire and needle resistance could not be determined.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "upon insertion of guidewire, guidewire became to unravel causing difficulty in removing the wire from the arm and needle.Upon removal of the wire, wire was physically unraveled and coiled.Patient did not have any complications or pain, and this did not harm the patient.Staff had to use another kit to place the line in this patient which was successful".
Additional Manufacturer Narrative
(b)(4).Corrected data: section b.3.-date of event corrected to (b)(6) 2024.Medwatch received - #mw5157742.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "upon insertion of guidewire, guidewire became to unravel causing difficulty in removing the wire from the arm and needle.Upon removal of the wire, wire was physically unraveled and coiled.Patient did not have any complications or pain, and this did not harm the patient.Staff had to use another kit to place the line in this patient which was successful".

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 19943346
• Report Number: 9680794-2024-00745
• Device Sequence Number: 4877555
• Product Code: LJS
• UDI-Device Identifier: 30801902120756
• UDI-Public: (01)30801902120756(11)240131(17)250523(10)33F24A0425(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 05/23/2025
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 33F24A0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown