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

Model Number	IPN920375
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "detachment of a distal fragment during dilator insertion." a new device was used.No patient harm or injury reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one image showing a cath-lab sheath/dilator assembly within its respective tray.It was observed that the dilator was inserted into the hemostasis end of the sheath, which is not the intended assembly during packaging.This indicates that the customer handled the device.No obvious defects/anomalies were observed on the sheath.The customer also returned one, opened cath-lab kit for analysis.The sample matches what is pictured in the customer photo.No obvious signs of use in the form of biological material was observed.Visual analysis of the sheath and dilator did not reveal any relevant defects or anomalies.The sheath length measured 4 9/16", which is within the specification limits of 3 7/8"-4 3/4" per the sheath product drawing.The sheath inner diameter at the distal tip measured 0.098", which is within the specification limits of 0.097"-0.099" per the sheath product drawing.The sheath outer diameter measured 0.127", which is within the specification limits of 0.124"-0.128" per the sheath extrusion product drawing.The returned dilator was able to be removed and reinserted back into the sheath with little to no issue.It was noted that the dilator hub was able to snap into the sheath cap.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage".The report of a sheath body separation was not able to be confirmed through complaint investigation.Visual analysis did not reveal any defects or anomalies on the returned sheath or dilator.Additionally, the sheath met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "detachment of a distal fragment during dilator insertion." a new device was used.No patient harm or injury reported.The patient's condition is reported as fine.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17809264
• Report Number: 9680794-2023-00715
• Device Sequence Number: 20513154
• Product Code: DQY
• UDI-Device Identifier: 00801902002143
• UDI-Public: 00801902002143
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Model Number: IPN920375
• Device Catalogue Number: CP-07711
• Device Lot Number: 14F23C0129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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: Female