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

Catalog Number	CL-07965
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "prior to the procedure according to ifu, the md found sheath valve rubber out phenomenon occurs." associated complaints: 9680794-2024-00927.
Additional Manufacturer Narrative
(b)(4).The customer returned one cath-lab sheath/dilator 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 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 initial defects or anomalies were observed with any portion of the psi, the dilator, nor the cap.During functional testing of the returned sample, a kink formed on the sheath/dilator.This kink prevented the dilator from being retracted.Sections of the dilator and sheath had to be intentionally severed to free the dilator.Dimensional analysis was performed on one of the seal slits, which measured to be 0.026", which is not within the specification limits of 0.035-0.045" per the seal product drawing.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.Resistance was encountered from inside the hemostasis valve.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".A device history record review was performed, and no relevant findings were identified.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.
Event or Problem Description
It was reported that "prior to the procedure according to ifu, the md found sheath valve rubber out phenomenon occurs." associated complaints: 9680794-2024-00927.

• 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: 20246093
• Report Number: 9680794-2024-00934
• Device Sequence Number: 7301672
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: (01)00801902002075(11)240424(17)290331(10)14F24D0226(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/26/2024

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 Catalogue Number: CL-07965
• Device Lot Number: 14F24D0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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