MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB; INTRODUCER CATHETER

Catalog Number	CDC-21242-1A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one mac sheath and one guide wire, alongside the product lidstock, for evaluation.The dilator was not returned.Visual inspection of the guide wire revealed two gradual bends near the proximal end.Microscopic inspection confirmed the damage.Both welds were present and observed to be full and spherical.Visual inspection of the dilator could not be performed as it was not returned for analysis.The bends in the guide wire measured 430mm and 450mm from the distal end.The guide wire total length measured 456mm which is within the specifications per product drawing.The guide wire outer diameter (od) measured 0.84mm which is within the specifications per product drawing.Dimensional inspection of the dilator could not be performed as it was not returned for analysis.Functional inspection of the guide wire as performed per the instructions-for-use (ifu) provided with the kit which states, "thread tapered tip of dilator/access device assembly over spring-wire guide.Grasping near skin, advance assembly with slight twis ting motion to a depth sufficient to enter vessel." the guide wire was threaded through a lab inventory dilator with no resistance.Functional inspection of the dilator could not be performed as it was not returned for analysis.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed several bends in the guide wire.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review based on sales history was performed with no relevant findings.The dilator was not returned, and thus the report of guide wire/dilator resistance could not be confirmed.Based on these circumstances, and without the dilator returned for analysis, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "we received an arrowg+ard blue mac two-lumen central venous access (catheter) where the wire would not thread through the cannula".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19790504
• Report Number: 9680794-2024-00765
• Device Sequence Number: 20605178
• Product Code: DYB
• UDI-Device Identifier: 50801902116821
• UDI-Public: 50801902116821
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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 Catalogue Number: CDC-21242-1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NONE REPORTED
• Patient Sex: Unknown