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

Catalog Number	CL-07645
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during removal of sheath, the sheath became difficult to removal, sheath become disconnected at hub and un-ribbon".The patient had no harm or injury.
Event or Problem Description
It was reported "during removal of sheath, the sheath became difficult to removal, sheath become disconnected at hub and un-ribbon".The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer returned one sheath extension assembly for analysis.The dilator was not returned.Signs of use were observed.Visual inspection revealed that the sheath body was partially separated from the hemostasis valve directly adjacent to the juncture hub.The coiled portion of the sheath body remained attached to the juncture hub.Microscopic evaluation of the separation points on the sheath and hemostasis hub revealed the sheath extrusion separation appeared jagged and stretched.After dimensional analysis was completed, the hemostasis hub was cross sectioned to view the internal connection point.The outer diameter of the sheath body measured 0.1110", which is within the specification limits of 0.111" - 0.115" per the sheath/dilator assembly drawing.The inner diameter for the sheath tip measured 0.0865", which is within the specification limits of 0.085"-0.087" per the sheath/dilator assembly drawing.Functional inspection could not be performed due to the separation of the returned device.Manufacturing was contacted and indicated that based on the cross-sectional images of the hemostasis hub, this issue could be related to the extrusion/wrapping process or the molding process.A device history record review was performed and no relevant findings were identified.The instructions for use (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 sheath body separation was confirmed through investigation of the returned sample.Visual analysis revealed that the sheath body had become partially separated from the hemostasis hub.Microscopic examination revealed that sheath extrusion appeared stretched at the separation points.The hemostasis hub was cross sectioned to view the internal connection point.The components passed all relevant dimensional requirements.Manufacturing was contacted as part of this complaint investigation.Based on review of the cross sectioned images, they indicated that root cause may be manufacturing related.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 21584430
• Report Number: 9680794-2025-00232
• Device Sequence Number: 8757716
• Product Code: DQY
• UDI-Device Identifier: 00801902001856
• UDI-Public: (01)00801902001856(11)230914(17)280831(10)14F23J0109(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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-07645
• Device Lot Number: 14F23J0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 44 KG