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

Catalog Number AO-09000

Device Problem Fitting Problem (2183)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: mac was inserted in the cvor.A day or two later the swan was removed in the icu and an individual ao-09000 (obturator component) was used to try and cap off the sheath.The obturator cap would not fit over the psi; therefore, they were not able to properly secure the psi with obturator cap.The clinician wedged as much of it as they could onto the mac.The mac was discontinued later that day and no other additional procedure was needed.The mac had reached end of therapy.No patient harm was reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: mac was inserted in the cvor.A day or two later the swan was removed in the icu and an individual ao-09000 (obturator component) was used to try and cap off the sheath.The obturator cap would not fit over the psi; therefore, they were not able to properly secure the psi with obturator cap.The clinician wedged as much of it as they could onto the mac.The mac was discontinued later that day and no other additional procedure was needed.The mac had reached end of therapy.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one mac catheter and an obturator for analysis.It was reported by the customer that the mac catheter is from a cdc-21242-xcn1a kit; however, the lot number for this cdc kit was not provided.Signs of use in the form of biological material were observed on the mac catheter.Initial visual analysis did not reveal any defects or anomalies.After performing functional testing (see below), it was observed that the returned obturator was not able to be inserted over the hemostasis cap of the mac catheter.Further analysis revealed that a build-up of congealed biological material had become lodged inside the sheath.Once the biomaterial was cleared, the obturator appeared to be inserted over the cap as intended.The outer diameter of the extrusion within the obturator that is meant to be inserted into the hemostasis cap of mac catheter measured.1055", which is within the specification limits of.1030"-.1070".The inner diameter of the obturator measured.440", which equals the nominal value of.440" per the product drawing.Per the report that the mac catheter is from a cdc-21242-xcn1a kit, the cap hemostasis valve product drawing was reviewed.The inner diameter of the valve measured.125", which is within the specification limits of.124"-.128".The outer diameter of the cap measured.433, which is within the specification limits of.427"-.437" per the product drawing.The returned obturator was inserted over the returned mac hemostasis cap.Major resistance was encountered, which prevented the cap from being locked over the cap.Performed per ifu statement from the cdc-21242-xcn1a kit reported, "use arrow obturator, either included with this product or sold separately, as dummy catheter with hemostasis valve assembly".A lab inventory obturator was inserted over the hemostasis cap.Major resistance was encountered, which prevented the obturator from locking into place.A lab inventory 8fr swan ganz catheter was inserted through the mac catheter.Minor resistance was encountered due to a build-up of congealed biological material, which was observed exiting the distal end of the sheath.Once all biological material was cleared from the mac, the obturator was inserted back over the cap.Little to no resistance was encountered as the obturator was able to lock into place, which is the intended function.To test the internal hemostasis valve, the mac was tested per amrq-000038, which states, "when tested as described in annex e of bs en iso 11070, using a test pressure of 38-42 kpa maintained for 30s, there shall be no leakage sufficient to form one of more falling drops of water".The mac extension lines were attached to the lab leak tester and pressurized to 40kpa for 30 seconds.No leakage was observed, which indicates that the internal valve is functioning as intended.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use arrow obturator, either included with this product or sold separately, as dummy catheter with hemostasis valve assembly.This will ensure that leakage does not occur and inner seal is protected from contamination".The ifu also states, "flush and connect distal side port to appropriate line as necessary.Confirm and monitor proximal port by aspirating until free flow of venous blood is observed.Connect all extension lines to appropriate luer-lock line(s) as required".The report of obturator connection not secure was confirmed through complaint investigation.Visual analysis revealed that the obturator would not fit over the returned mac.Further analysis revealed a large build-up of congealed biological material inside the mac body.Once cleared the obturator appeared to fit and lock over the mac as intended.Additionally, the returned mac and obturator met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 15643264
• MDR Text Key: 302402519
• Report Number: 9680794-2022-00649
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: PERCUTANEOUS SHEATH INTRODUCER (PSI).; PERCUTANEOUS SHEATH INTRODUCER (PSI).