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

Catalog Number	CP-07611
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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 the dilator split.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 6fr introducer sheath and lidstock for analysis.The dilator was not returned.Upon receipt, a non-arrow straightener component was inserted into the distal hub of the sheath.Signs of use were observed.Three attempts were made to acquire additional information from the customer.No response was received.Visual analysis revealed no defects or anomalies on the returned sheath.The inner diameter of the hemostasis valve cap measured 0.1455" which is within the specification limits of 0.144"-0.147" per product specification drawing.The returned sheath was functionally tested using a lab inventory 6fr dilator.After removing the non-arrow straightener from the distal hub of the sheath, the dilator was inserted.No resistance was encountered.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user "do not use if package has been previously opened or damaged." the report of a split dilator could not be confirmed through examination of the returned sample.The customer returned one 16fr introducer sheath and non-arrow straightener for evaluation.The dilator was not returned.Visual analysis of the returned sheath revealed no defects or anomalies.The returned sheath passed all relevant dimensional and functional testing.A device history record review was performed, and no relevant findings were identified.Three attempts were made to acquire additional information, but no response was received.Without the dilator to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the dilator split.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: 21925850
• Report Number: 9680794-2025-00356
• Device Sequence Number: 8650630
• Product Code: DQY
• UDI-Device Identifier: 00801902002129
• UDI-Public: (01)00801902002129(11)210218(17)260131(10)14F21B0056(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,Followup
• Report Date (Section B): 04/04/2025

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
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: CP-07611
• Device Lot Number: 14F21B0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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