MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: after inserting the wire into the blue syringe, the wire cannot be pulled out.Additional information: there was no reported patient harm or consequence.They were reported as fine post the procedure.The complaint was changed to reportable after device return and it was found to be kinked as this is a reportable incident.Mdr awareness date is the 02jan2024.

Manufacturer Narrative

Qn # (b)(4).The customer provided two photos for evaluation.The report of swg/ars resistance could not be confirmed through inspection of the photos.The customer returned one arrow raulerson syringe (ars), one guide wire, and the product lidstock for evaluation.Signs of use were observed on the returned components, and the guide wire was returned within its advancer tube.Visual inspection of the guide wire revealed one kink and offset coils throughout the body.The distal j-bend was observed to be misshapen but intact.Microscopic examination confirmed the damage.Both welds were present and appeared to be full and spherical.Visual inspection of the ars revealed no obvious defects or anomalies.The kink in the guide wire measured 370mm from the distal end.The offset coils in the guide wire measured 18mm from the distal end.The guide wire total length measured 602mm which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.800mm which is within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the product instructions for use (ifu) which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was inserted through the returned ars.No resistance was observed while threading the guide wire.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user, "warning: do not aspirate arrow raulerson syringe while guidewire is in place; air may enter syringe through rear valve." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed two kinks in the guide wire.The guide wire and ars met all relevant dimensional and functional requirements; therefore the report of guide wire/ars resistance could not be confirmed.A device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: after inserting the wire into the blue syringe, the wire cannot be pulled out.Additional information: there was no reported patient harm or consequence.They were reported as fine post the procedure.The complaint was changed to reportable after device return and it was found to be kinked as this is a reportable incident.Mdr awareness date is the 02jan2024.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18433894
• MDR Text Key: 331875530
• Report Number: 3006425876-2024-00018
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: 00801902102324
• 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: 01/02/2024

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 Catalogue Number: CS-25703-E
• Device Lot Number: 71F22L1069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• 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