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

Model Number	IPN055156
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " they catheterize and when they remove the guidewire, they notice pressure (it doesn't come out smoothly).They take out the entire catheter and it comes out frayed." anatomical insertion site of the device: neck device removed and used another catheter successfully but therapy got delayed, no harm to the patient.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The image revealed unraveling from the distal end, confirming the customer report.The customer also returned one guide wire for analysis.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled from the distal weld and has multiple kinks in the guide wire body.The distal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The major kinks in the guide wire body were measured at 360, 436, and 440mm from the proximal tip.The broken core wire measured 453mm in length, which is within the specification limits of 449.2-458.8 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.434 mm which is within the specification limits of 0.432-0.457 mm per guide wire product drawing.Functional inspection could not be performed for this complaint investigation due to the damage to the returned guide wire and without the catheter returned for analysis.A manual tug test confirmed that the proximal weld was intact.Additional testing of the catheter could not be performed as the catheter was not returned.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 that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld.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 2.0 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 likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " they catheterize and when they remove the guidewire, they notice pressure (it doesn't come out smoothly).They take out the entire catheter and it comes out frayed." anatomical insertion site of the device: neck.Device removed and used another catheter successfully but therapy got delayed, no harm to the patient.

• Brand Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20062956
• Report Number: 3006425876-2024-00829
• Device Sequence Number: 12927351
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)201023(17)241130(10)71F20K1587(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 11/30/2024
• Device Model Number: IPN055156
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F20K1587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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
• Patient Sex: Unknown