MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Model Number	IPN033013
Medical Device Problem Codes	Unraveled Material (1664); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "in two instances, dysfunctional catheters were found, in which the guidewire bent and presented difficulty in passing through.On one occasion, it became stuck in the patient.No harm was caused to the patient." the reporter was unaware of how the guidewire was removed from the patient.No medical intervention was reported.It was reported on the third attempt the catheter was successfully placed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 9680794-2023-00410.
Event or Problem Description
The complaint is reported as: "in two instances, dysfunctional catheters were found, in which the guidewire bent and presented difficulty in passing through.On one occasion, it became stuck in the patient.No harm was caused to the patient." the reporter was unaware of how the guidewire was removed from the patient.No medical intervention was reported.It was reported on the third attempt the catheter was successfully placed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of an unravelled guide wire was confirmed by visual inspection of the customer supplied photo.A full complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the 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".A device history record review was performed, and no relevant findings were identified.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.However, without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Associated mdr#s: 9680794-2023-00410; 9680794-2023-00411.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17173446
• Report Number: 9680794-2023-00411
• Device Sequence Number: 7333666
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: 30801902124310
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: IPN033013
• Device Catalogue Number: CS-12402
• Device Lot Number: 14F20L0067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• 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 Age: 5 MO
• Patient Sex: Unknown