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

Catalog Number CL-07724

Device Problem Obstruction of Flow (2423)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during the procedure, the physician found the sheath can't flush.A new kit was opened to finish the procedure.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned multiple components of a cath-lab sheath set, including one dilator, sheath, and product lidstock, for analysis.No definite signs of use were observed.Visual analysis of the sheath did not reveal any obvious defects or anomalies.The overall length of the sheath measured 9 3/4" which is within the specification limits of 8 7/18" - 9 6/8" per the sheath/dilator product drawing.The outer diameter of the sheath measured 0.12785" which is within the specification limits of 0.124" - 0.128" per the sheath extrusion graphic.The instructions for use (ifu) provided with this kit instructs the user, "ensure dilator hub fully snaps into sheath cap.Thread tapered tip of sheath/dilator assembly over guidewire.Grasping near skin, advance assembly into vessel with slight twisting motion to desired position." the returned dilator was advanced through the sheath and the hub snapped into place with little to no resistance.Then a lab inventory guide wire was advanced through the sheath/dilator assembly, and little to no resistance was encountered.The sheath was also flushed through the sidearm using a lab inventory ars, and the sheath was able to flush as intended.No blockages were identified.Per ifu statement "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 this kit informs the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary.".The customer report of a blocked sheath could not be confirmed through investigation of the returned sample.The sheath passed all relevant visual, dimensional, and functional requirements, and a device history record review revealed no relevant findings.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported during the procedure, the physician found the sheath can't flush.A new kit was opened to finish the procedure.The patient's condition is reported as fine.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17719657
• MDR Text Key: 323072815
• Report Number: 9680794-2023-00705
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902001900
• UDI-Public: 00801902001900
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CL-07724
• Device Lot Number: 14F22C0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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