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

Catalog Number CL-07965

Device Problems Break (1069); Material Separation (1562)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported "during the procedure according to ifu, the md identified that valve breakage occurred.So the md opend up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The pateint's current condition is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one psi sheath assembly for analysis.Signs-of-use in the form of biological material were observed.Visual inspection of the sheath revealed that the sheath internal seal was separated from the rest of the assembly.The seal is intended to rest inside the valve body.Further functional analyses (see below) revealed that the internal seal exits from the proximal opening of the cap when removing the dilator from the assembly.Microscopic examination of the seal slits revealed that they were not uniform in length.No physical defects or anomalies were observed with any portion of the psi, the dilator, or the cap.Dimensional analysis was performed on one of the seal slits, which measured to be 0.0245" which is not within the specification limits of 0.035-0.045".The hemostasis cap was removed to reassemble the components.The seal was placed within the hemostasis valve and the cap reassembled.The dilator was inserted through the sheath.Major resistance was encountered from inside the hemostasis valve; the dilator was not able to fully advance and snap into the cap, which is not the intended function.Upon removal of the dilator, the internal seal was observed to cling to the surface of the dilator.This resulted in the seal to completely exit through the cap of the hemostasis valve.Performed per instructions-for-use (ifu) provided with this kit which states, "ensure dilator hub fully snaps into sheath cap".Additional testing was not required as part of this complaint investigation.All complaints are trended across product families on a monthly basis.A device history record review was performed, and relevant findings were identified.Non-conformances were created for material this material and lot number regarding a sheath valve separation.The ifu provided with the kit was reviewed as part of this complaint investigation.A non-conformance was initiated to further investigate this complaint issue.The customer complaint of a valve assembly separation was confirmed through complaint investigation.Visual analysis revealed that the internal seal was located on the outside of the hemostasis valve body and over the dilator extrusion.This is not the intended assembly.Further functional analysis revealed that the seal exits through the hemostasis cap when the dilator is withdrawn.Dimensional analysis revealed that the slits on the internal seal are not within specification.Based on the customer report, the sample received, and the comments from manufacturing, the root cause is likely supplier related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19164756
• MDR Text Key: 340956957
• Report Number: 9680794-2024-00357
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: 00801902002075
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CL-07965
• Device Lot Number: 14F23G0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2023
• 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