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 Codes	Product Quality Problem (1506); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or sheath/dilator assembly as this can lead to vessel perforation, bleeding, or component damage." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).The report that the guide wire separated was confirmed through examination of the returned sample.The customer returned one opened cvc kit with one guide wire for analysis.No definite signs of use were observed on the guide wire.Visual analysis revealed that the guide wire was unraveled and separated.One kink was additionally observed at the distal j-bend, causing it to appear slightly misshapen.The separated portion of the guide wire was not returned for analysis.The distal weld appeared to be full and spherical.The appearance of the guide wire was as intended; no roughness was observed.The kink on the guide wire measured 19mm using a calibrated ruler from the distal tip.The overall length of the guide wire core wire measured 376mm with a calibrated ruler which is not within the specification limits of 449.2-458.8mm per the guide wire product drawing.Therefore, at least 73.2mm of the guide wire was missing and not returned for analysis.The outer diameter (od) of the guide wire measured 0.520mm using a calibrated caliper which is within the specification limits of 0.508-0.533mm per the guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.Additional documents reviewed included the guide wire product drawing and the ifu provided with this kit (s-15703-112a) which informs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." in conclusion, the guide wire was unraveled and separated, however, the separated portion was not returned.The intact portion of the guide wire met relevant od requirements.No manufacturing defects were found during this investigation.Arrow guide wires of this od 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.The damage on the guide wire is consistent with unintentional use error; however, without the complete guide wire returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found the swg tip rough feel/appearance during used on the patient.The swg tip pierce of blood vessel wall." the patient was reported as "good".Additional information has been requested from the account.

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18299960
• Report Number: 3006425876-2023-01221
• Device Sequence Number: 15243967
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)200804(17)250803(10)71F20G2829(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2023

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
• Device Expiration Date: 08/03/2025
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F20G2829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 05/10/2024; Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/03/2024; 05/14/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown