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

Catalog Number	CL-07924
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found dilator tip broken.So the md opened up the new kit to finish the procedure." 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 cath lab sheath with the associated dilator inserted.Signs of preparation were noted on the device.The dilator hub was completely missing and there were markings that looked like it used to be there.A minor scuff was noted on the tip of the dilator consistent with signs of use.No other damage was seen on any part of the unit.The dilator measured 0.126", which was within specification limits.The dilator was advanced and removed from the sheath without resistance.The sheath was successfully flushed through the sidearm with the dilator inserted.A device history review was performed and there was one finding; however, it was determined the finding was not relevant to the reported event.The instructions for use (ifu) provided with this kit warns 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 reported broken dilator noticed during the procedure was able to be confirmed through investigation of the returned product.The unit was returned for investigation, and the dilator was missing from the hub.There was minor wear on the tip and imprints on the proximal end where the hub likely used to be.No other damage was noted.The outer diameter of the dilator measured within specification limits at 0.126".The dilator successfully advanced through the sheath without resistance and flushed properly through the sidearm.A capa has been previously initiated for this issue.Based on the capa investigation and returned product, the root cause is likely design related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found dilator tip broken.So the md opened up the new kit to finish the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 23247759
• Report Number: 9680794-2025-00831
• Device Sequence Number: 10245664
• Product Code: DQY
• UDI-Device Identifier: 00801902002051
• UDI-Public: (01)00801902002051(11)230327(17)280229(10)14F23C0188(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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-07924
• Device Lot Number: 14F23C0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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; NOT REPORTED
• Patient Sex: Unknown