MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number EU-45854-CVCPS

Device Problem Stretched (1601)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "while infusing the contrast fluid into the dedicated line, they noticed a swelling in the distal part of the line.They continued the procedure by clamping the infusion line without using it." it was reported the catheter was not removed.The extension line was clamped and the procedure continued by using another extension line.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer provided two photos for reference.The pressure injection device is pictured.The customer also returned one 4-l catheter for analysis.Signs of use were observed on the catheter.Visual analysis revealed that the medial extension line (gray luer hub) was stretched.There was a clear indication of where the extension line began to balloon.The damage is consistent with the line being over-pressured.However, the customer specified that they used a flow rate of 3ml/sec, which is lower than the maximum specification of 10ml/sec for a 4-lumen 8.5fr x 20cm catheter per the pi info card provided (c-15703-301).The total length of the catheter body measured 216 mm, which is within specifications of 207-227 mm per catheter product drawing.The inner diameter of the medial extension line at the undamaged portion measured 0.057", which is within specifications of 0.055-0.059" per medial extrusion graphic.The outer diameter of the medial extension line at the undamaged portion measured 0.0851", which is within specifications of 0.084-0.088" per medial extrusion graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all of the extension lines were flushed with water using a lab inventory syringe, and the extension lines flushed as intended.No blockages or leaks were found.A manual tug test confirmed the distal, medial, and proximal lines were secure to their luer hubs.R & d and quality engineers were contacted as a part of this complaint investigation.They stated that a material defect, a thin extension line wall, or block or occlusion in the catheter lumen could also result in the observed damage.To test the catheter, a 100% flow/leak test is performed to identify internal lumen blockages.Per functional testing, no blockages were found within the lumens when flushed, so it cannot be confirmed whether a blockage caused or contributed to the ballooning/stretching of the extension line.The customer did not provide a lot number; therefore, a device history record review was performed based upon two potential lot numbers.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300psi) to reduce risk of intraluminal leakage or catheter rupture." the customer complaint of a stretched/ballooned extension line was confirmed by a visual inspection of the returned sample.The medial line (gray hub) of the catheter was found to be stretched out.The customer specified that a flow rate of 3ml/sec was used during the procedure, which is below the maximum flow rate specification.The catheter passed all relevant dimensional and functional requirements, and a device history record review performed based on sales history revealed no relevant findings.Based on the customer report, the sample returned, and comments from r & d, the potential root cause cannot be determined.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "while infusing the contrast fluid into the dedicated line, they noticed a swelling in the distal part of the line.They continued the procedure by clamping the infusion line without using it." it was reported the catheter was not removed.The extension line was clamped and the procedure continued by using another extension line.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 15317188
• MDR Text Key: 301770379
• Report Number: 3006425876-2022-00749
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EU-45854-CVCPS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: CONTRAST; CONTRAST