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

Catalog Number	CP-07611
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during the procedure according to ifu, the md found the dilator to be faulty.So the md opened up the new kit to finish the procedure.".
Additional Manufacturer Narrative
(b)(4) the customer returned one, opened cath lab sheath intro set including the sheath extension assembly with dilator for analysis.Signs of use in the form of biological material were observed on the returned components.Visual analysis of the dilator revealed the tip was damaged/deformed.The dilator length measured 6 15/16", which is within the specification limits of 6 3/4" - 7 1/4" per dilator product drawing.The dilator inner diameter at the distal tip measured 0.039", which is within the specification limits of 0.039"-0.041" per dilator product drawing.The dilator was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "thread tapered tip of sheath/dilator assembly over guidewire.Grasping near skin, advance assembly into vessel with slight twisting motion to desired position." a lab inventory 0.877 mm guide wire was threaded through the returned dilator.A blockage in the form of excess biological material was observed within the dilator.Once the blockage was removed, the guide wire advanced through with little to no resistance.R & d and manufacturing have been consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the dilator tip, including the manufacturing process and/or undue force applied unintentionally by the user during an attempted insertion.A device history record review was performed, and no relevant findings were identified.The ifu provided with the 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 report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual analysis revealed the dilator tip was damaged/deformed with evidence of use.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect occurred during use and the appearance of the damage, the root cause cannot be determined as it cannot be determined when the damage occurred.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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20835738
• Report Number: 9680794-2024-01187
• Device Sequence Number: 3863327
• Product Code: DQY
• UDI-Device Identifier: 00801902002129
• UDI-Public: (01)00801902002129(11)230727(17)280630(10)14F23G0198(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: CP-07611
• Device Lot Number: 14F23G0198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Unknown