MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07126
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " initially we tried to do the right heart catheterization from the right median vein but we could not advance theswan's balloon and then i tried to pull the balloon out but it got stuck and although it was not inflated multiple attempt to remove the balloon was not successful then the balloon was pulled out to slowly and when i got the balloon out there was some tissue stuck to the balloon for no known reason as the balloon was never inflated inside the vein and it is not clear if this tissues is part of the vein or part of the subcutaneous tissue.Immediately after removing the swan-ganz catheter the area was compressed with a pressure dressing".Additional information states that "was able to complete via femoral vein".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).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 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 " initially we tried to do the right heart catheterization from the right median vein but we could not advance theswan's balloon and then i tried to pull the balloon out but it got stuck and although it was not inflated multipleattempt to remove the balloon was not successful then the balloon was pulled out to slowly and when i got theballoon out there was some tissue stuck to the balloon for no known reason as the balloon was never inflatedinside the vein and it is not clear if this tissues is part of the vein or part of the subcutaneous tissue.Immediatelyafter removing the swan-ganz catheter the area was compressed with a pressure dressing".Additional information states that "was able to complete via femoral vein".The patient's current condition is reported as "fine".

• Brand Name: ARROW CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22699139
• Report Number: 3010532612-2025-00711
• Device Sequence Number: 15740753
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)250520(17)261031(10)16F25E0010(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• 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): 07/07/2025

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: AI-07126
• Device Lot Number: 16F25E0010
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown