MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 16CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-01618

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

Patient Problem Discomfort (2330)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: obese male patient in hemorrhagic shock with need of constant arterial pressure monitoring.3 attempts with 3 different sets.They were unable to remove the swg from the vessel without the swg unravelling.Associated complaints: - tc# (b)(4) for device #1.- tc# (b)(4) for device #2.- tc# (b)(4) for device #3.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter simultaneously.Use of excessive force may damage catheter or spring-wire guide".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

It was reported that: obese male patient in hemorrhagic shock with need of constant arterial pressure monitoring.3 attempts with 3 different sets.They were unable to remove the swg from the vessel without the swg unravelling.Associated complaints: (b)(4) for device #1; (b)(4) for device #2; (b)(4) for device #3.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18057047
• MDR Text Key: 327185454
• Report Number: 3006425876-2023-01035
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102829
• UDI-Public: 00801902102829
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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 Catalogue Number: SAC-01618
• Device Lot Number: 71F20D1523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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.