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

Catalog Number CA-27702

Device Problem Material Deformation (2976)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the spring wire guide was kinked prior to patient use.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened 2-l cvc kit for evaluation.The guide wire in the kit was returned within its advancer tubing and showed no clear signs of use.Visual examination of the guide wire revealed two bends in the guide wire body, near the distal tip.During normal assembly these bends would have been located inside the straightener tubing, protecting it from damage.However, the straightener tubing and end cap were not present in the returned assembly.The distal j bend was found to be slightly misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The bends in the guide wire body were located at 26 mm and 43 mm from the distal end.The total length of the guide wire measured to be 603 mm which is within specifications of 596-604 mm per swg product drawing.The outer diameter of the guide wire measured to be 0.801 mm which is within specifications of 0.788-0.826 mm per product drawing.The ifu provided with this kit states the following: "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into intr oducer needle." "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." the returned guide wire was advanced through a lab inventory ars and a lab inventory 18 ga introducer needle.The swg was able to pass through each component with minimal resistance.A manual tug test confirmed both welds were fully intact on the guide wire.Manufacturing was contacted regarding this issue, and they reported that no defects were found by the vision system station which inspects the finished assembly in any of the guide wire components for the reported material and batch numbers.This indicates that the damage was unlikely to occur during manufacturing assembly.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The ifu provided with this kit states: "do not use if package has been previously opened or damaged." the customer report of guide wire damage before use was confirmed by investigation of the returned sample.Visual analysis confirmed the guide wire had two bends near the distal end.During normal assembly these bends would have been located inside the straightener tubing, protecting the guide wire from damage.It was determined by manufacturing that the damage was unlikely to occur during the assembly process as the finished samples were checked by an automated system and no defects were found at the time of inspection.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Therefore, the root cause of this failure is undetermined.Teleflex will continue to monitor and trend reports of this nature.

Event Description

It was reported the spring wire guide was kinked prior to patient use.No patient involvement.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12583235
• MDR Text Key: 274950544
• Report Number: 9680794-2021-00496
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/14/2021

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 Expiration Date: 11/30/2022
• Device Catalogue Number: CA-27702
• Device Lot Number: 13F21A0659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• 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