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

Model Number IPN033013

Device Problems Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).Associated mdr#s: 9680794-2023-00410.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 317859495
• Report Number: 9680794-2023-00411
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: 30801902124310
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 5 MO