MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the doctor found the swg kinked during use on the patient during the insertion.They changed a new one to resolve the issue." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc set containing several components, including one guide wire, one 2-l catheter, and one 21 ga introducer needle for analysis.The guide wire was returned partially advanced within the catheter and showed evidence of use.Visual inspection of the returned guide wire revealed several kinks in its body.Microscopic examination confirmed the damage.The distal j-bend was intact.Both welds were observed to be present and appeared to be full and spherical.Visual inspection of the catheter also revealed several bends towards the distal end, in the same locations as the kinks in the guide wire.The kink in the guide wire measured 117mm, 155mm and 165mm from the proximal end.The total length of the guide wire measured 455mm, which is within the specifications of 449.2-458.8mm per product drawing.The guide wire outer diameter (od) measured 0.44mm, which is within the specifications of 0.432-0.457mm per product drawing.The kinks in the catheter body measured 5mm, 30mm, and 42mm from the distal tip.The catheter body length measured 5 1/8" which is within the specifications of 4 13/16"-5 3/16" per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a lab inventory guide wire of the same dimensions as the returned guide wire (od: 0.44mm was threaded through the distal lumen of the catheter.Minor resistance was encountered at the kinked portions of the catheter.A manual tug test confirmed the distal and proximal welds are intact.A 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 a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed kinks in the guide wire and catheter.The returned guide wire and catheter met all relevant dimensional and functional requirements.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the doctor found the swg kinked during use on the patient during the insertion.They changed a new one to resolve the issue." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 19444827
• Report Number: 3006425876-2024-00528
• Device Sequence Number: 14256470
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: 00801902102140
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/06/2024

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-14402
• Device Lot Number: 71F23C2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown