MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported: the swg was kinked, found prior to use during testing.No patient involved.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The report that the spring wire guide was kinked was confirmed through examination of the returned sample.One kink was observed towards the distal end of the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire would be protected within the protective tubing of the advancer assembly, however, the end cap was missing from the returned assembly.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported: the swg was kinked, found prior to use during testing.No patient involved.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18397286
• MDR Text Key: 331501599
• Report Number: 3006425876-2023-01232
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: 00801902102287
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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: CS-24703-E
• Device Lot Number: 71F22L0303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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