MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number ES-04301

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: " on (b)(6) 2024, during the insertion, the doctor found the swg kinked during used on the patient." the patient was reported as fine.

Event Description

It was reported that: on (b)(6) 2024, during the insertion, the doctor found the swg kinked during used on the patient." the patient was reported as fine.

Manufacturer Narrative

(b)(4).The customer report of a kinked guide wire during use was confirmed through examination of the returned sample.The customer returned multiple components of a cvc kit, including one guide wire assembly and arrow raulerson syringe (ars), for analysis.Visual analysis of the guide wire revealed that it contained one kink towards the distal end.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: CVC SET: 5 FR X 20 CM
• 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: 18985363
• MDR Text Key: 338667667
• Report Number: 3006425876-2024-00301
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: 10801902122756
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• 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: 03/03/2024

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 Catalogue Number: ES-04301
• Device Lot Number: 71F22F3929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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