MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "according to the report of the surgeon, the guide wires frayed and became entangled during the procedure." there was no medical intervention required.The patient's current condition is reported as "unknown".Additional information has not been provided at this time.Associated mdr numbers: 3006425876-2024-01039.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "according to the report of the surgeon, the guide wires frayed and became entangled during the procedure." there was no medical intervention required.The patient's current condition is reported as "unknown".Additional information has not been provided at this time.Associated mdr numbers: 3006425876-2024-01039.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned two images.The first image showed two different lidstocks ((b)(4)).The second image showed multiple defective guide wires.Visual analysis confirmed kinking on the guide wires.The customer returned one guide wire and one lidstock for analysis.The lidstock appears to match the (b)(4) lidstock shown in the customer image.Signs-of-use were observed on the guide wire.Visual analysis revealed kinking along the guide wire body.The distal j-bend was misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The guide wire length measured 17 7/8" , which is within the specification limits of 17 11/16"-18 1/16" per the guide wire product drawing.The guide wire outer diameter measured 0.0205", which is within the specification limits of 0.020"-0.021" per the guide wire product drawing.The guide wire was inserted through a lab inventory 20ga introducer needle.Resistance was encountered at the location of the kinking; however, the functional section passed as intended.Performed per ifu statement , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the proximal and distal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the reported 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 ifu also states, "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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed kinking on the guide wire.The guide wire met all relevant dimensional and functional requirements, and a device history record review on the reported finished good did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2L 5 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: 20585467
• Report Number: 3006425876-2024-01040
• Device Sequence Number: 8575524
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)240424(17)290331(10)71F24D0993(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/08/2024

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-14502
• Device Lot Number: 71F24D0993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown