MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-16553-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "there have been difficulties with the insertion of the dilator for the central venous pressure (cvp) catheter due to bifurcation at the distal end".A new set was used to complete the procedure.The condition of the patient is reported to be 'fine'.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for analysis.Signs of use were observed inside the dilator extrusion, which confirms that it was used.Visual analysis revealed that the dilator tip was widened.Microscopic examination confirmed the damage and revealed white stress marks around the damage.A bend was also noted around the middle of the extrusion.The bend on the dilator measured 45mm from the hub.The dilator body length measured 3", which is within the specification limits of 2 3/4"-3 1/4" per the dilator product drawing.The dilator inner diameter at the distal tip measured 0.022", which is within the specification limits of 0.022"-0.024" per dilator product drawing.The dilator inner diameter at the proximal end measured 0.040", which is within the specification limits of 0.040"-0.043" per dilator extrusion product drawing.A lab inventory guide wire was threaded through the dilator tip.Despite the damage to the tip, the guide wire passed with no resistance.Biological material was observed exiting the dilator along with the guide wire.Performed per ifu statement instructs the user , "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was widened.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings to suggest a manufacturing issue.Based on the customer report that the defect occurred during use and the appearance of the damage to the tip, the root cause appears consistent with damage due to undue force when inserting the dilator over the guide wire; however, the root cause cannot be determined as it is unknown if the damage occurred before or after the customer handled.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "there have been difficulties with the insertion of the dilator for the central venous pressure (cvp) catheter due to bifurcation at the distal end".A new set was used to complete the procedure.The condition of the patient is reported to be 'fine'.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 20978200
• Report Number: 9680794-2024-01252
• Device Sequence Number: 4033097
• Product Code: DQY
• UDI-Device Identifier: 30801931122981
• UDI-Public: (01)30801931122981(11)240418(17)280531(10)14F24D0175(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Catalogue Number: CS-16553-E
• Device Lot Number: 14F24D0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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