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

Catalog Number	CL-07980
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found the sheath leak during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Event or Problem Description
It was reported that "the doctor found the sheath leak during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one sheath extension assembly for analysis.The dilator was not returned.Signs of use were observed.Visual analysis revealed that the seal within the hemostasis hub was missing.No other defects or anomalies were observed.The length of the sheath from the hemostasis hub to the distal tip measured 31 and 11/16", which is within the specification limits of 30 7/8"-31 7/8" per the sheath/dilator assembly product drawing.The outer diameter of the sheath body measured 0.1525", which is within the specification limits of 0.151"-0.155" per the sheath/dilator assembly product drawing.The inner diameter of the sheath tip measured 0.1255", which is within the specification limits of 0.124"-0.126" per the sheath/dilator assembly drawing.A device history record review was performed, and no relevant findings were identified.The customer complaint of a sheath hub leak was confirmed through complaint investigation.Visual analysis revealed the internal seal was missing from the hemostasis hub.The sheath passed all relevant dimensional analysis.Based on the customer report and the sample received, the root cause is manufacturing related.A non-conformance has been initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 21548465
• Report Number: 9680794-2025-00212
• Device Sequence Number: 12805617
• Product Code: DQY
• UDI-Device Identifier: 00801902002082
• UDI-Public: (01)00801902002082(11)230921(17)280831(10)14F23J0013(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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-07980
• Device Lot Number: 14F23J0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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