MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI JACC KIT: 3-L 6 FR X 25 CM CG+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42563-JX1A
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: catheter was placed on (b)(6) 2024, then found to be kinked in the soft tissues on (b)(6) 2025 with poor blood return.One of the nurses pulled it back to see if the kink would smooth out and if the line would then work.As she pulled the catheter back, she noted the split and removed the catheter.The split is found around the 20cm mark.Patient received a new jacc placement after this catheter was removed.Additional information: the catheter was placed saturday night.On sunday the patient was very agitated and moving alot.Nurses had to hold her while they attempted to give iv sedation through the catheter.They used force and were unsuccessful, pivs were inserted and used for sedation.A chest xray then showed that the line was kinked.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: catheter needed to be removed prior to therapy completion.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided four photos for analysis.One photo showed an x-ray image.The other photos showed the catheter outside of the patient.Visual analysis confirmed that the catheter body was ruptured adjacent to the 20 marking.The tear appears uniform and in the direction of the extrusion.The catheter body also appeared kinked and was bulging slightly at the location of the tear.This is damage consistent with over-pressurizing; however, a full visual analysis could not be performed as the sample was not returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use only lumen(s) labeled 'pressure injectable' for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information".The ifu also states, "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".The customer report of ruptured catheter body was confirmed by visual inspection of the customer supplied photos.The images show a hole in the catheter body that appears consistent with a pressure related rupture.The extrusion is also observed to be kinked in the location of the damage which can contribute to pressure build-up.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.
Event or Problem Description
It was reported that: catheter was placed (b)(6) 2024, then found to be kinked in the soft tissues on (b)(6) with poor blood return.One of the nurses pulled it back to see if the kink would smooth out and if the line would then work.As she pulled the catheter back, she noted the split and removed the catheter.The split is found around the 20cm mark.Patient received a new jacc placement after this catheter was removed.Additional information: the catheter was placed saturday night.On sunday the patient was very agitated and moving alot.Nurses had to hold her while they attempted to give iv sedation through the catheter.They used force and were unsuccesful, pivs were inserted and used for sedation.A chest xray then showed that the line was kinked.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: catheter needed to be removed prior to therapy completion.

• Brand Name: ARROW PI JACC KIT: 3-L 6 FR X 25 CM CG+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 18957525
• Report Number: 9680794-2024-00246
• Device Sequence Number: 21193738
• Product Code: LJS
• UDI-Device Identifier: 50801902123911
• UDI-Public: 50801902123911
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: CDC-42563-JX1A
• Device Lot Number: 33F23K0351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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.
• Patient Sex: Unknown