MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	CA-11142
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the integrity of the dilator was compromised." the tip of the dilator was damaged during insertion into the patient.The user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".
Event or Problem Description
It was reported "the integrity of the dilator was compromised." the tip of the dilator was damaged during insertion into the patient.The user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one dilator and a lidstock.Signs of use were observed inside the dilator body.Visual analysis of the dilator revealed widening at the distal tip.Microscopic examination revealed evidence of white stress marks.The appearance of the widening is consistent with damage due to undue force applied unintentionally by the user during an attempted insertion.The dilator length measured 8 1/8", which is within the specification limits of 8 1/32"-8 9/32" per the dilator product drawing.The dilator inner diameter at the distal tip measured 0.037", which is within the specification limits of 0.036"-0.038" per the dilator product drawing.A lab inventory guide wire was inserted through the dilator tip.Despite the damage to the tip, the guide wire was able to pass completely through the dilator extrusion.Performed per ifu statement , "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".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 use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was widened and slightly misshapen.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings to suggest a manufacturing issue.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 is unknown if the damage occurred before or after the customer handled.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• 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: 20797567
• Report Number: 9680794-2024-01170
• Device Sequence Number: 15448787
• Product Code: DYB
• UDI-Device Identifier: 10801902024418
• UDI-Public: (01)10801902024418(11)240425(17)290228(10)33F24E0733(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: CA-11142
• Device Lot Number: 33F24E0733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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