MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC STIMUCATH SFTY KIT: 19G CTH, 17GX9CM NDL; ANESTHESIA CONDUCTION KIT

Model Number IPN923213

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: during an attempt to remove the inner guidewire, the blue end fell off, the wire was removed but the catheter unraveled and kinked towards the tip.This occurred twice.The same issue occurred with another patient with the same device lot.There was no injury.

Event Description

Reported issue: during an attempt to remove the inner guidewire, the blue end fell off, the wire was removed but the catheter unraveled and kinked towards the tip.This occurred twice.The same issue occurred with another patient with the same device lot.There was no injury.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: STIMUCATH SFTY KIT: 19G CTH, 17GX9CM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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 ; 9194332672
• MDR Report Key: 16726859
• MDR Text Key: 313167552
• Report Number: 1036844-2023-00030
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10801902206180
• UDI-Public: 10801902206180
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121403
• 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: 03/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN923213
• Device Catalogue Number: AB-05060-PKS
• Device Lot Number: 13F23A0886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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.