MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH

Catalog Number ASK-04001-VCUH3

Device Problem Material Deformation (2976)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "nurse was attempting to advance the peel-away into a young patient with tough skin and the peel-away accordioned about 1 cm below the proximal end.The sheath was replaced with a gault sheath and the procedure was completed without incident".No patient harm or injury.The patient's current condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows a peel-away sheath/dilator assembly with signs of crimping on the peel-away sheath body and tip.Therefore, the complaint of peel-away sheath body damaged was able to be confirmed by the photo, however, a complete visual inspection could not be performed as no sample was returned for analysis.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, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding." without the device to evaluate, 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

It was reported "nurse was attempting to advance the peel-away into a young patient with tough skin and the peel-away accordioned about 1 cm below the proximal end.The sheath was replaced with a gault sheath and the procedure was completed without incident".No patient harm or injury.The patient's current condition reported as "fine.".

• Brand Name: ARROW ACCESS TRAY
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18658364
• MDR Text Key: 336074973
• Report Number: 1036844-2024-00003
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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 Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: ASK-04001-VCUH3
• Device Lot Number: 33F23E0090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Female