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

Catalog Number	CL-07745
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that 26 sep 2025, during clinical use of our sheath, it was found that the sealing cap on the sheath tube had cracked." the user changed to a new set to resolve the issue.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 submitted two photos for analysis.The photos show the hub of a cath-lab sheath.The hub of a dilator is visible protruding from the sheath cap.A crack is visible on the side of the sheath cap.The customer also returned one sheath and dilator for analysis.Signs of use in the form of biological material were observed.The dilator was returned advanced through the sheath.Visual analysis revealed a crack in the side of the sheath cap.The sheath cap was not fully seated onto the sheath hub.The dilator was removed from the sheath for further inspection.Minor deformation was observed on the dilator hub.The outer diameter of the dilator body at the proximal end measured 0.097" which is within the specification limits of 0.096"-0.099" per product drawing.The outer diameter of the distal end of the dilator hub measured 0.151" which is within the specification limits of 0.149"-0.151" per product drawing.The inner diameter of the sheath cap measured 0.1452" which is within the specification limits of 0.144"-0.147" per product drawing.The outer diameter of the sheath cap measured 0.3888" which is within the specification limits of 0.385"-0.395" per product drawing.The outer diameter of the proximal end of the sheath hub measured 0.348" which is within the specification limits of 0.345"-0.349" per product drawing.Manufacturing, design assurance, and sustaining engineering were all contacted as part of this investigation.The manufacturing molding team stated that while fractures in the cap related to the molding process are possible, they typically occur on the weld line of the part.The crack observed is located on the side of the cap and does not appear consistent with a molding deficiency.Based on discussion with design assurance, it is possible that exposure to chemicals/disinfectants may contribute to the cracking observed.Additional information was requested from the customer regarding what disinfectants were used.No response was received.Sustaining engineering also stated that the observed cracking may be consistent with applied non-axial force with the dilator to the cap while trying to lock the dilator to the device as only one side of the dilator has the deformation.Attempts to replicate this damage with a lab inventory sample were unsuccessful.Additionally, no deformation/bending was observed at the connection between the dilator hub and dilator body of the returned unit.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this device states, "do not apply excessive force in removing guidewire or sheath/dilator." additionally, "hemostasis valve must be occluded at all times to minimize the risk of air embolism or hemorrhage." the customer report of a cracked sheath cap was able to be confirmed through investigation of the returned sample.Visual analysis revealed cracking in the hemostasis sheath cap.The returned sample passed all relevant dimensional inspection.A device history record (dhr) review was performed, and no relevant findings were identified.Manufacturing, design assurance, and sustaining engineering were contacted as part of this investigation.The manufacturing molding team stated that the observed damage is inconsistent with a molding deficiency.Sustaining engineering also stated that the observed cracking may be consistent with applied non-axial force with the dilator to the cap while trying to lock the dilator to the device as only one side of the dilator has the deformation; however, attempts to replicate this damage with a lab inventory sample were unsuccessful.Additional information was requested from the customer regarding which disinfectants were used on the device; however, no response was received.Based on the customer report and the sample received, the most likely root cause is undeterminable.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "(b)(6) 2025, during clinical use of our sheath, it was found that the sealing cap on the sheath tube had cracked." the user changed to a new set to resolve the issue.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: 23335049
• Report Number: 9680794-2025-00851
• Device Sequence Number: 9948983
• Product Code: DQY
• UDI-Device Identifier: 00801902001931
• UDI-Public: (01)00801902001931(11)240229(17)290131(10)14F24B0292(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/26/2025

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 Catalogue Number: CL-07745
• Device Lot Number: 14F24B0292
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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