MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

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

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that" on (b)(6) 2023, the doctor found the swg can't pull out of the ars.The swg kinked during used on the patient.The patient was reported as fine.

Event Description

It was reported that"23 dec 2023, the doctor found the swg can't pull out of the ars.The swg kinked during used on the patient.The patient was reported as fine.

Manufacturer Narrative

(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned one, opened cvc kit for analysis.The guide wire and arow raulerson syringe (ars) will be analysed as part of this complaint investigation.Signs-of-use were observed on the guide wire.The guide wire was returned fully advance through the ars.Slight kinking was observed on the guide wire directly adjacent to the distal j-bend.The guide wire was completely removed.A kink was observed towards the distal end of the body.Microscopic examination confirmed the kink on the guide wire body.Both welds were present and were observed to be full and spherical.The kink on the guide wire was located 583mm via calibrated ruler from the proximal weld.The overall length of the guide wire measured 603mm via calibrated ruler, which is within the specification of 596mm-604mm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.790mm via calibrated caliper, which is within the specification of 0.788mm-0.826mm per the guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through the returned ars and a lab inventory 18ga introducer needle.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested".A device history record review was performed, and no relevant manufacturing issues were identified.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: ARROW CVC SET: 2-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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18632623
• MDR Text Key: 334499717
• Report Number: 3006425876-2024-00132
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/08/2024

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-27702-E
• Device Lot Number: 71F22L1491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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