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

Catalog Number	SI-09880
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patient who is placed with a temporary pacemaker and does not seal the valve, allowing blood to pass through the sheath." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "patient who is placed with a temporary pacemaker and does not seal the valve, allowing blood to pass through the sheath." 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 provided two photos for analysis.The first image shows an arrow flex sheath whilst inside the patient.A large amount of biological material is visible inside the cath-gard, which confirms the report that the sample leaked.Further analysis of the second image shows the lidstock of the arrow sheath and the non-arrow inserted catheter.The non-arrow catheter appears to be 6fr, which is below the intended size for sheaths of this type.Per the lidstock of the arrow kit, the psi is intended to be used with 7-7.5fr catheters.Despite these findings, the root cause cannot be determined without the sample returned for analysis.A device history record review was performed and no relevant findings were identified.The lidstock artwork was reviewed as part of this complaint.The lidstock clearly states , "percutaneous sheath introducer set with integral hemostasis valve/side port for use with 7 - 7.5 fr.Catheter".The ifu provided with the kit informs the user, "using devices not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury".The customer report of leaking valve was confirmed by visual inspection of the customer supplied photos; however, the psi involved with this complaint is intended to be used with 7-7.5fr catheters.Per the customer photos, a 6fr non-arrow device is pictured, which suggests that the customer used a catheter size that is too small; however, without the device returned for analysis, a full 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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 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: 22186789
• Report Number: 3006425876-2025-00527
• Device Sequence Number: 21005159
• Product Code: DYB
• UDI-Device Identifier: 00801902102874
• UDI-Public: (01)00801902102874(11)241109(17)291031(10)14F24J0266(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K780532
• 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): 05/19/2025

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
• Device Catalogue Number: SI-09880
• Device Lot Number: 14F24J0266
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2024
• 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