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); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " on (b)(6) 2025, during the placement of product, blood leakage was observed both inside and outside the sheath protective sleeve, resulting in contamination of the pulmonary artery catheter (pac) and rendering it unusable, which delayed the treatment time." associated complaints 3006425876-2026-00006.
Additional Manufacturer Narrative
Qn# (b)(4).The complaint of a cath-gard sleeve detaching from the hub was confirmed through complaint investigation of the returned sample.The customer returned one opened psi sheath, 7fr swan-ganz catheter, and a cath-gard for analysis.The sterile tubing was found to be disconnected from the front hub.The o-ring was not secured to the hub or sleeve portion of the cath-guard.The cath-gard passed all relevant functional testing and was able to be reassembled to function as expected.The ifu provided with the kit informs the user, "slide entire catheter contamination shield to proximal end of catheter." a device history record review was performed, and no relevant findings were identified.Based on the sample returned, unintentional use error likely caused or contributed to this event.
Event or Problem Description
It was reported that: "(b)(6) 2025, during the placement of product, blood leakage was observed both inside and outside the sheath protective sleeve, resulting in contamination of the pulmonary artery catheter (pac) and rendering it unusable, which delayed the treatment time." associated complaints 3006425876-2026-00016 and 3006425876-2026-00006.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23971769
• Report Number: 3006425876-2026-00016
• Device Sequence Number: 8909522
• Product Code: DYB
• UDI-Device Identifier: 00801902102874
• UDI-Public: (01)00801902102874(11)230920(17)280128(10)71F23J0591(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 71F23J0591
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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