MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Model Number IPN036821

Device Problem Malposition of Device (2616)

Patient Problem Perforation of Vessels (2135)

Event Date 08/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Physician used ultrasound to identify the right internal jugular vein.He got flashback with the introducer.Put the guidewire down.Advanced a 2 lumen psi in the usual fashion.It was discovered later when the patient had a thoracotomy, that the sheath went through the vessel.It was reported the patient had a gunshot wound to the right upper quadrant.A chest tube was placed in the emergency room.After the sheath was placed the patient experienced a hemothorax with significant pneumothorax, estimated 3 to 5 liters of blood.A thoracotomy was performed for the increased output from the chest tube.On exploration of the gunshot wound the surgeon saw the sheath in the thorax.It was reported the increased output from the chest tube was related to the injury caused by the sheath.The vessel was repaired at the same time as the gunshot wound injury.The patient survived and was discharged 2-3 days later.

Manufacturer Narrative

(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

Physician used ultrasound to identify the right internal jugular vein.He got flashback with the introducer.Put the guidewire down.Advanced a 2 lumen psi in the usual fashion.It was discovered later when the patient had a thoracotomy, that the sheath went through the vessel.It was reported the patient had a gunshot wound to the right upper quadrant.A chest tube was placed in the emergency room.After the sheath was placed the patient experienced a hemothorax with significant pneumothorax, estimated 3 to 5 liters of blood.A thoracotomy was performed for the increased output from the chest tube.On exploration of the gunshot wound the surgeon saw the sheath in the thorax.It was reported the increased output from the chest tube was related to the injury caused by the sheath.The vessel was repaired at the same time as the gunshot wound injury.The patient survived and was discharged 2-3 days later.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12618529
• MDR Text Key: 276125349
• Report Number: 9680794-2021-00529
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30801902122248
• UDI-Public: 30801902122248
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN036821
• Device Catalogue Number: AK-21142-SK
• Device Lot Number: 13F21D0327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention