MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number	SI-09880
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "undergoing tavi procedure in operation theatre.Using a 7.5 fr swan ganz catheter.Leaking happens during the case.Interfere with the procedure, need to use gauze, plaster, and tape to slow down the leak.Also, patient need blood transfusion".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two videos for analysis.The complaint of sheath valve leak in use was able to be confirmed from the videos as they revealed clear visual evidence of blood exiting the device from the hemostasis valve while inserted into the patient.A complete visual inspection to evaluate the cause of the leak could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: hemostasis valve must be occluded at all times to reduce the risk of air embolism, contamination or hemorrhage.In the absence of an indwelling central catheter use the arrow obturator to occlude hemostasis valve." the complaint of sheath valve leak in use was able to be confirmed from the customer supplied videos as they revealed clear visual evidence of blood exiting the device from the hemostasis valve while inserted into the patient.However, full complaint verification testing to evaluate the cause of the leak could not be performed as no sample was returned for analysis.Without the device to evaluate, 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 "undergoing tavi procedure in operation theatre.Using a 7.5 fr swan ganz catheter.Leaking happens during the case.Interfere with the procedure, need to use gauze, plaster, and tape to slow down the leak.Also, patient need blood transfusion.".

• Brand Name: ARROW PSI SET: 8.5 FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21404207
• Report Number: 3006425876-2025-00176
• Device Sequence Number: 20886611
• Product Code: DYB
• UDI-Device Identifier: 00801902102874
• UDI-Public: (01)00801902102874(11)230818(17)270728(10)71F23H0914(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: SI-09880
• Device Lot Number: 71F23H0914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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