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

Catalog Number CV-17702-E

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported "the doctor found the swg tip kinked during used on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the doctor found the swg tip kinked during used on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer provided one photo for evaluation.The report of a kinked guide wire was confirmed through visual inspection of the photo.The customer also returned one opened cvc set with multiple components, including one guide wire in its advancer tube and an arrow raulerson syriinge (ars) for evaluation.Signs of use were observed on the guide wire.Visual inspection of the guide wire revealed offset coils towards the distal end of the body.The distal j-bend was deformed and misshapen.Microscopic examination confirmed the damage.Both welds were present and observed to be full and spherical.The offset coils in the guide wire measured 5-7mm from the distal end.The guide wire total length measured 601mm which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.80mm which is within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit 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 threaded through the returned ars and a lab inventory introducer needle with no resistance.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 , "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." the customer report of a kinked guide wire was conformed through complaint investigation of the returned sample.Visual inspection revealed offset coils towards the distal end of the guide wire body.The returned guide wire met all relevant dimensional and functional requirements, and 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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18977991
• MDR Text Key: 338666092
• Report Number: 3006425876-2024-00287
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: 00801902105455
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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: CV-17702-E
• Device Lot Number: 71F22J3370
• 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: 02/29/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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: NONE REPORTED; NONE REPORTED