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

Catalog Number	CL-07645
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the valve of catheter leaked.The staff tells me that they have had the same problem with the other models.".Additional information reported "faulty valve in the sheath when injecting through sidearm, contrast was leaked with high velocity toward operator and staff." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include 9680794-2024-00280 and 9680794-2024-00279.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported "the valve of catheter leaked.The staff tells me that they have had the same problem with the other models.".Additional information reported "faulty valve in the sheath when injecting through sidearm, contrast was leaked with high velocity toward operator and staff." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include 9680794-2024-00280, 9680794-2024-00279.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18997109
• Report Number: 9680794-2024-00293
• Device Sequence Number: 12814150
• Product Code: DQY
• UDI-Device Identifier: 00801902001856
• UDI-Public: 00801902001856
• Combination Product (Y/N): N
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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-07645
• Device Lot Number: 14F23F0129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Male