MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN919472
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/29/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported "incident occurred on (b)(6) 2023.Under the effect of traction (patient having stood up), the infusion line of the catheter broke.(catheter inserted on 28 july).The doctor was called by nurses.Doctor instructed to immediately remove the catheter.When the nurses arrived, patient was in respiratory cardiac arrest.Cardiopulmonary resuscitation started by the paramedical team and call for resuscitation.Patient deceased." it was reported by the hospital that the patient had been in follow-up care and rehabilitation department following a recent stroke."the paramedical team noticed that the catheter was cut, so they got the doctor on call, who gave instructions to remove the device.Patient was in cardiac arrest when they came back to the room." the time interval from when the issue was detected to death was 5 minutes.The cause of death is reported as "unexpected cardiorespiratory arrest".An autopsy was not performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "incident occurred on (b)(6) 2023.Under the effect of traction (patient having stood up), the infusion line of the catheter broke.(catheter inserted on (b)(6)).The doctor was called by nurses.Doctor instructed to immediately remove the catheter.When the nurses arrived, patient was in respiratory cardiac arrest.Cardiopulmonary resuscitation started by the paramedical team and call for resuscitation.Patient deceased." it was reported by the hospital that the patient had been in follow-up care and rehabilitation department following a recent stroke."the paramedical team noticed that the catheter was cut, so they got the doctor on call, who gave instructions to remove the device.Patient was in cardiac arrest when they came back to the room." the time interval from when the issue was detected to death was 5 minutes.The cause of death is reported as "unexpected cardiorespiratory arrest".An autopsy was not performed.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of extension line separated/torn during use was able to be confirmed by the photos.Both photos revealed that the distal extension line of the catheter was separated as the extension line hub was missing from the device.The separated hub is not visible in the photos, therefore , it cannot be confirmed where on the extension line the separation occurred.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Air embolism can occur if air is allowed to enter a central venous access device or vein.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection." the customer report of extension line separated/torn during use was confirmed by visual inspection of the customer supplied photos.Both photos revealed that the distal extension line of the catheter was separated as the extension line hub was missing from the device.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: 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: 17640914
• Report Number: 3006425876-2023-00811
• Device Sequence Number: 5680201
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: 00801902102119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN919472
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F22A0743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG