MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the issue appears to be that the catheter was deformed (flattened.Patient is fine.Replaced with a new one.".
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged sheath was confirmed by complaint investigation of the returned sample.The customer returned one, opened psi kit for analysis.Visual analysis confirmed that the location of the kink corresponds to where the sheath is in contact with the guidewire advancer assembly in the packaging.A device history record review was performed, and no relevant findings were identified.Based on the damage observed on both the sheath and protective tubing, packaging design likely caused or contributed to this defect.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that: "the issue appears to be that the catheter was deformed (flattened.Patient is fine.Replaced with a new one.".

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 24301908
• Report Number: 3006425876-2026-00128
• Device Sequence Number: 14756111
• Product Code: DYB
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)230217(17)270228(10)71F23B1251(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002507
• 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): 01/14/2026

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-11142
• Device Lot Number: 71F23B1251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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