MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number AK-25402

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Tachycardia (2095)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Customer reports wire is very flimsy and different than the wire in the ak-15402 kit.The physician had a hard time inserting the guidewire and the patient had an svt.The patient was reported to be ok.Additional information was requested, but not received at the time of this report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reports wire is very flimsy and different than the wire in the ak-15402 kit.The physician had a hard time inserting the guidewire and the patient had an svt.The patient was reported to be ok.Additional information was requested, but not received at the time of this report.

• Brand Name: ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 13655910
• MDR Text Key: 288024311
• Report Number: 9680794-2022-00139
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: AK-25402
• Device Lot Number: 13F21J0514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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