MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number	IPN920380
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "kinked and bent in the packaging at the top end.All damaged ones have been sorted out." the associated emdr report numbers are 9680794-2025-00148, 9680794-2025-00169, 9680794-2025-00170, 9680794-2025-00148 and 9680794-2025-00238.
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened cath-lab intro set for analysis.No damage was observed to the packaging.Visual analysis revealed bending of the sheath adjacent to the hemostasis hub within the packaging.The set was opened to analyze the contents within.Visual analysis confirmed that the sheath was bent adjacent to the hemostasis hub.The dilator was removed from the distal tip of the sheath.No other defects or anomalies were observed on the dilator or guidewire.The sheath length from the hemostasis hub to the distal tip measured 4 3/8" which is within the specification limits of 4 1/4" - 4 1/2" per the sheath extension assembly product drawing.The outer diameter of the sheath measured 0.940" which is within the specification limits of 0.091"-0.094" per the sheath extrusion product drawing.The inner diameter of the sheath measured 0.074" which is within the specification limits of 0.072"-0.074" per the sheath extension assembly product drawing.The length of the dilator from the distal tip to the hub measured 6 7/8" which is within the specification limits of 6 3/4"- 7 1/4" per the dilator product drawing.The inner diameter of the dilator at the distal tip measured 0.040" which is within the specification limits of 0.039"-0.041" per the dilator product drawing.The outer diameter of the dilator measured 0.0730" which is within the specification limits of 0.071"-0.074" per the dilator extrusion product drawing.The returned sheath was functionally tested per the instructions for use (ifu) provided with this kit.The ifu instructs the user, "ensure dilator hub fully snaps into sheath cap.Thread tapered tip of sheath/dilator assembly over guidewire." the dilator was passed through the sheath and snapped into the hemostasis hub with no resistance.The sheath/dilator assembly was then passed over the returned guidewire with no resistance.Manufacturing and packaging r & d and were contacted as part of this complaint investigation.The specific root cause was not definitively determined; therefore , a non-conformance has been initiated to further investigate this issue.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, "do not use if package is damaged." the customer report of a catheter kinked/bent was able to be confirmed through investigation of the returned sample.Visual analysis revealed that the returned sheath was bent adjacent to the hemostasis hub within the packaging.The unit was opened for further investigation, and it met all relevant dimensional and functional requirements.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "kinked and bent in the packaging at the top end.All damaged ones have been sorted out".The associated emdr report numbers are 9680794-2025-00148, 9680794-2025-00169, 9680794-2025-00170, 9680794-2025-00148.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 21593630
• Report Number: 9680794-2025-00238
• Device Sequence Number: 8349831
• Product Code: DQY
• UDI-Device Identifier: 00801902001573
• UDI-Public: (01)00801902001573(11)210917(17)260831(10)14F21J0040(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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 Expiration Date: 08/31/2026
• Device Model Number: IPN920380
• Device Catalogue Number: CP-08503-A
• Device Lot Number: 14F21J0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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