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

Catalog Number	CL-07965
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "when the user removed the dilator from the sheath before use, the hemostasis valve got detached with the dilator.T herefore, a new kit was used instead." this was found prior to use.There was no patient involvement.
Event or Problem Description
It was reported "when the user removed the dilator from the sheath before use, the hemostasis valve got detached with the dilator.T herefore, a new kit was used instead." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The customer returned the cath lab sheath with the dilator almost completely inserted.Signs of use in the form of biological material were noted on the device.The valve outside the hub and was torn.There was also some damage on the hub of the dilator.No other damage was noted on any other part of the device.Dimensional testing was done on the seal and the dilator.The outer diameter of the dilator was 0.124", which is within specifications based on the product drawing.The outer diameter of the seal was 8.42mm, which is above the upper specification limit.The slits of the seal measured 0.55mm, 0.68mm, and 0.71mm which are all below the lower specification limit.The width of the seal was 1.41mm which is above the upper specification limit.The specifications limits were based on the product drawing.The sheath as received (with the dilator inserted and valve dislodged) was flushed through side arm and water came out of hub.The dilator was attempted to be removed but it was not possible potentially due to dried blood in the lumen.The dilator was snipped in order to remove the valve for dimensional testing and visual inspection.A device history review was performed and there were six relevant findings for the seal component (s-088803-003, lot 14p23a0030).The non-conformances were all created for sheath valve dimension issues which is the same failure for this complaint.The ifu cautions the user " hemostasis valve must be occluded at all times to minimize the risk of air embolism or hemorrhage.If device introduction is delayed, or device is removed, temporarily cover valve opening with sterile-gloved finger until catheter or obturator is inserted.Use arrow obturator, either includedwith this product or sold separately, to occlude sheath.This will ensure that leakage does not occur and inner seal is protected from contamination".The customer complaint of the hemostasis valve detaching was confirmed through complaint investigation.Visual analysis revealed damage to the valve in the form of tearing.The valve was dislodged from the sheath valve sheath housing.The dilator hub was also damaged.It's unclear when or how the dilator hub damage occurred and it wasn't reported by the customer.Functional testing revealed that the dilator could not be advanced or removed in the sheath without severe resistance.Dimensional analysis revealed the slits on the internal seal were not within specification measuring at 0.55mm, 0.68mm, and 0.71mm.The outer diameter and width were both above the upper specification limit, measuring at 8.42mm and 1.41mm respectively.The dilator outer diameter was within measurement specification limits.Based on the customer report and the sample received, it was determined that the root cause is supplier related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "when the user removed the dilator from the sheath before use, the hemostasis valve got detached with the dilator.Therefore, a new kit was used instead." this was found prior to use.There was no patient involvement.

• 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: 22951908
• Report Number: 9680794-2025-00742
• Device Sequence Number: 13140381
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: (01)00801902002075(11)230803(17)280731(10)14F23G0230(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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-07965
• Device Lot Number: 14F23G0230
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 10/22/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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.; NOT REPORTED.
• Patient Sex: Unknown