MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15402-E
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
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "according to the report by 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 is not available at this time.Associated mdr numbers include: 9680794-2024-01078.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned two images.The first image showed two different lidstocks (cs-15402-e and cs-14502).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 cs-1502-e lidstock shown in the customer image.Signs of use were observed on the guide wire.Visual analysis confirmed that the guide wire was unraveled from the distal end.Further microscopic examination confirmed the unraveling and revealed that the distal weld was separated from the core and coil wires.The separated weld was not returned as part of the complaint.Kinking was also confirmed along the guide wire body.The guide wire length measured 16 7/8", which is not within the specification limits of 17 11/16"-18 1/16" per the guide wire product drawing.This indicates that 13/16"-1 3/16" of the core wire was separated and not returned for analysis.The guide wire outer diameter measured 0.017", which is within the specification limits of 0.017"-0.018" per the guide wire product drawing.A manual tug test confirmed that the proximal weld was 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 separated guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was unraveled from the distal end.Further visual and dimensional analysis revealed a section of the core wire (including distal weld) was separated and not returned for analysis.A device history record review on the reported finished good did not reveal any relevant findings.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 the customer report and the sample received, the appearance of the damage seems consistent with undue force being applied during insertion or removal; however, the root cause is undetermined as a section of the guide wire was separated and not returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "according to the report by 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 is not available at this time.Associated mdr numbers include: 9680794-2024-01078.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 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: 20585448
• Report Number: 9680794-2024-01079
• Device Sequence Number: 8575128
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: (01)10801902099645(11)200906(17)250731(10)14F20G0127(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 Expiration Date: 07/31/2025
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 14F20G0127
• 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: 09/06/2020
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown