MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW OBTURATOR COMPONENT: .50"; INTRODUCER CATHETER

Catalog Number AO-09000

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported prior incident in which the obturator cap that comes inside the mac cdc-21242-xcn1a kit fits properly, but the ao-09000 (obturator component) when used at a later date does not fit properly.It was reported the clinical team does not have any further information regarding this patient experience.There was no report of patient harm.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 Description

Customer reported prior incident in which the obturator cap that comes inside the mac cdc-21242-xcn1a kit fits properly, but the ao-09000 (obturator component) when used at a later date does not fit properly.It was reported the clinical team does not have any further information regarding this patient experience.There was no report of patient harm.

• Brand Name: ARROW OBTURATOR COMPONENT: .50"
• Type of Device: INTRODUCER CATHETER
• 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: 15643307
• MDR Text Key: 307041723
• Report Number: 9680794-2022-00650
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780532
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AO-09000
• Device Lot Number: 14F21D0351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Treatment: MAC CATHETER CDC-21242-XCN1A.; MAC CATHETER CDC-21242-XCN1A.