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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: " sheath broke off handle".Post insertion of a jacc through the sheath, when beginning to tear away the sheath, the white "handle" or tab tore away from the rest of the sheath leaving only the other tab and the sheath intact.To remove the sheath, i manually pushed the catheter along the line of the sheath where it is intended to tear away, opening only one side of the sheath.The sheath was removed completely and the procedure was completed.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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: " sheath broke off handle".Post insertion of a jacc through the sheath, when beginning to tear away the sheath, the white "handle" or tab tore away from the rest of the sheath leaving only the other tab and the sheath intact.To remove the sheath, i manually pushed the catheter along the line of the sheath where it is intended to tear away, opening only one side of the sheath.The sheath was removed completely and the procedure was completed.There was no reported patient harm or consequence.".

• 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: 20300457
• Report Number: 9680794-2024-00947
• Device Sequence Number: 7744939
• Product Code: LJS
• UDI-Device Identifier: 50801902123911
• UDI-Public: (01)50801902123911(11)240404(17)250831(10)33F24B0517(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153423
• Number of Events Summarized: 1
• Summary Report (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): 09/03/2024

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: 08/31/2025
• Device Catalogue Number: CDC-42563-JX1A
• Device Lot Number: 33F24B0517
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• 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