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

Catalog Number	SI-21142
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the surgical procedure, difficulties arose while attempting to insert the mac introducer catheter into the patient.Despite multiple attempts under ultrasound guidance, the anesthesiologist noted that the tip of the device was bent and showed signs of wear, preventing proper placement.A replacement introducer was opened; however, upon inspection, it exhibited the same defect (deformed and deteriorated tip).Given this issue, the head of pharmacy was immediately notified, and a third device was requested.Fortunately, the final unit was found to be in optimal condition, allowing the procedure to be successfully completed." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened mac kit for analysis.No definite signs of use were observed on any of the returned components.Visual analysis of the mac catheter revealed very slight bending around the skive holes of the mac body.Visual analysis also revealed kinking on the guide wire and widening/tearing on the dilator tip.The kinking/bending on the catheter measured 15-20mm from the distal tip.The length from the juncture hub to the distal tip measured 98mm, which is within the specification limits of 97mm-103mm per the sheath product drawing.The mac body outer diameter measured 4.61mm, which is within the specification limits of 4.59mm-4.71mm per the sheath extrusion product drawing.The customer report of a kinked catheter was confirmed through the complaint investigation.Visual analysis revealed that the catheter was slightly bent towards the distal tip.The sample passed all relevant dimensional requirements.It was determined the root cause for this complaint is manufacturing related.A capa was implemented on 07-november-2024 to address this failure.The mac lot numbers involved with this complaint were manufactured in may 2024, which is prior to the implementation date of the capa (nov 2024).Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "during the surgical procedure, difficulties arose while attempting to insert the mac introducer catheter into the patient.Despite multiple attempts under ultrasound guidance, the anesthesiologist noted that the tip of the device was bent and showed signs of wear, preventing proper placement.A replacement introducer was opened; however, upon inspection, it exhibited the same defect (deformed and deteriorated tip).Given this issue, the head of pharmacy was immediately notified, and a third device was requested.Fortunately, the final unit was found to be in optimal condition, allowing the procedure to be successfully completed." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW MULTI-LUMEN/PSI SET
• 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: 21950139
• Report Number: 9680794-2025-00364
• Device Sequence Number: 8800454
• Product Code: FOZ
• UDI-Device Identifier: 00801902102911
• UDI-Public: (01)00801902102911(11)240903(17)260516(10)14F24H0141(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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 Expiration Date: 05/16/2026
• Device Catalogue Number: SI-21142
• Device Lot Number: 14F24H0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: Female