MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919476
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: after uncomplicated placement of cvc for dialysis in subclavian vein, during withdrawal of a guide wire, the guide wire became uncoiled.The cvc was withdrawn along with uncoiled guide wire.There was no reported patient harm.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided three photos for analysis.The report of an unraveled guide wire was confirmed through visual inspection of the photos.The customer also returned one guide wire for evaluation.The guide wire was unraveled and showed evidence of use.Visual inspection of the guide wire revealed it was unraveled from the distal end.One kink and several bends were observed on the guide wire.Microscopic examination confirmed the damage, and confirmed the core wire separated adjacent to the distal weld.The separated core wire tip was discolored at the point of separation.The distal weld was present at the end of the coil wire and appeared full and spherical.The proximal weld was present and appeared full and spherical.The kink in the guide wire measured 235mm from the proximal end.The broken core wire length measured 684mm which is within the specifications of 678-688mm per product drawing; therefore, no pieces of the core wire appear to be missing.The guide wire outer diameter measured 0.84mm which is within the specifications of 0.838-0.877mm per product drawing.Functional inspection of the guide wire could not be performed due to the damage.A manual tug test confirmed the proximal weld was intact.Device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the 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 customer report of an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed the guide wire was unraveled from the distal end.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.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, 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: after uncomplicated placement of cvc for dialysis in subclavian vein, during withdrawal of a guide wire, the guide wire became uncoiled.The cvc was withdrawn along with uncoiled guide wire.There was no reported patient harm.
Event or Problem Description
It was reported that: after uncomplicated placement of cvc for dialysis in subclavian vein, during withdrawal of a guide wire, the guide wire became uncoiled.The cvc was withdrawn along with uncoiled guide wire.There was no reported patient harm.
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18397429
• Report Number: 3006425876-2023-01280
• Device Sequence Number: 14486555
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: (01)00801902102164(11)230612(17)280531(10)71F23F0458(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN919476
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F23F0458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/22/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/22/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG