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

Catalog Number CS-45854-HP

Device Problem Material Rupture (1546)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "63 year old male patient , critically ill, intubated, undergoing ctpa - contrast injection via grey lumen - commence run at 5ml/min at which the pressure peaked and lowered at a steady rate.Doctor then noticed slight movement of patient in scanner, after which sounded like a loud pop.The clinical staff said that the cvc extension may have "kinked" over during ct pressure injection, the lumen was not able to withstand those pressures and blew the lumen.Therapy was delayed but there was no other reported patient harm or consequence and they were reported as fine.

Manufacturer Narrative

Qn#(b)(4) the customer report of a ruptured extension line was confirmed through complaint investigation of the returned sample.The customer returned one 4-l pressure injectable cvc for evaluation.Signs-of-use were observed on the catheter body and inside the extension lines.Visual inspection of the grey medial extension line revealed the line was ruptured most of the way down the extension line.A kink was also observed on the extension line, adjacent to the ruptured portion of the line.The returned catheter met all relevant dimensional and functional requirements, and a device history record review was performed based on sales history with no relevant findings.Based on the customer report, and the comments from r & d, the damage appears consistent with inadvertent over pressurization of the extension line during use.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: "63 year old male patient , critically ill, intubated, undergoing ctpa - contrast injection via grey lumen - commence run at 5ml/min at which the pressure peaked and lowered at a steady rate.Doctor then noticed slight movement of patient in scanner, after which sounded like a loud pop.The clinical staff said that the cvc extension may have "kinked" over during ct pressure injection, the lumen was not able to withstand those pressures and blew the lumen.Therapy was delayed but there was no other reported patient harm or consequence and they were reported as fine.

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18984917
• MDR Text Key: 338662779
• Report Number: 3006425876-2024-00271
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-45854-HP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 63 YR
• Patient Sex: Male