MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number	IPN921162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cath-lab kit for analysis.Large quantities of biological material were observed inside the sheath side-arm.It was noted that the side arm stopcock was in the unlocked position.A lab inventory syringe filled with water was attached to the side-arm stopcock and aspirated.A slight blockage was initially encountered; however, almost immediately, large quantities of congealed biological material were observed exiting the sheath body.Once cleared of all biological material, the sheath flushed as intended.Performed per ifu "prepare sheath for insertion by flushing through side arm".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "check lumen placement by holding sheath in place and withdrawing guidewire and dilator sufficiently to allow blood flow to be aspirated into side port.Flush and connect side port to appropriate line, as necessary".Corrective action is not required as part of this complaint as unintentional use error likely caused or contributed to this event.The report of a blocked side arm was confirmed through complaint investigation.Visual and functional analysis revealed large quantities of congealed biological material were observed inside the sheath extrusion.Once cleared, the sheath flushed as intended.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the build-up of congealed biological material is the source of the blockage encountered.Therefore, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "blockage in lumen (rubber part) trough which there was no back flow possible.Therapy was delayed but there was no other patient harm or consequence.".

• Brand Name: CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19979718
• Report Number: 9680794-2024-00767
• Device Sequence Number: 8374922
• Product Code: DQY
• UDI-Device Identifier: 00801902001948
• UDI-Public: (01)00801902001948(11)230920(17)280831(10)14F23J0155(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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 Model Number: IPN921162
• Device Catalogue Number: CL-07780
• Device Lot Number: 14F23J0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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
• Patient Sex: Unknown