MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 4" ( 10 CM) A; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-21142-GMC

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported dilator with flared tip.No report of patient harm.Details of use unknown.The anesthesia director reported that since there was blood on it and it was in a bio bag it was probably during use and that if there were any patient complications they would have been reported to him.

Manufacturer Narrative

(b)(4).

Event Description

Customer reported dilator with flared tip.No report of patient harm.Details of use unknown.The anesthesia director reported that since there was blood on it and it was in a bio bag it was probably during use and that if there were any patient complications they would have been reported to him.

Event Description

Customer reported dilator with flared tip.No report of patient harm.Details of use unknown.The anesthesia director reported that since there was blood on it and it was in a bio bag it was probably during use and that if there were any patient complications they would have been reported to him.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 9 fr.Dilator for evaluation.Visual inspection of the sample revealed a damaged dilator tip.The dilator tip looked split and frayed.This damage is consistent with undue force being applied during an attempted guide wire or dilator insertion.The dilator body total length form the end of the hub to the distal tip measured 8 1/4" which is within the specification of 8 1/32"- 8 9/32" per dilator product drawing.The dilator outer diameter measured 0.1185" which is within the specification of 0.117"-0.120" per product drawing.The dilator tip inner diameter could not be measured accurately due to the damage to the tip.A lab inventory guide wire with a diameter of.035" was inserted through the dilator.Little to no resistance was observed as the guide wire passed through the assembly.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: do not apply excessive force in removing guide wire, dilator or access device.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the dilator tip was split.The appearance of the damage is consistent with undue force being applied during insertion.The dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 4" ( 10 CM) A
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 13581229
• MDR Text Key: 286071374
• Report Number: 9680794-2022-00117
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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: 04/30/2023
• Device Catalogue Number: ASK-21142-GMC
• Device Lot Number: 13F21F1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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