MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PSI KIT: 9 FR; INTRODUCER CATHETER

Catalog Number	AK-09903-A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "when product opened, sheath was bent, able to use for purpose of volume however not able to float swan ganz catheter.".
Additional Manufacturer Narrative
(b)(4).The customer complaint of a sheath damaged in use was not able to be confirmed by complaint investigation of the returned sample.The customer returned one, opened psi kit including one undamaged, representative sheath assembly and dilator for evaluation.The customer stated that a representative sample would be returned for investigation.No signs of use were observed on both components.Visual inspection revealed no obvious defects or anomalies on the returned components.Visual inspection of the actual complaint sample could not be performed as it was not returned.The sheath body length measured 4 1/4" via calibrated ruler, which was within the specifications of 4" - 4 1/4" per sheath assembly product drawing.The sheath body outer diameter (od) measured 0.15120" via calibrated micrometer, which was within the specification of 0.1495"-0.1545" per sheath extrusion graphic.Dimensional inspection of the actual complaint sample could not be performed as it was not returned.The returned dilator was able to pass through the returned sheath with minimal resistance.Functional inspection of the actual complaint sample could not be performed as it was not returned.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage." a device history record review was performed, and no relevant findings were identified.Based on these circumstances, no root cause can be determined without the reported, defective sample re turned.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: "when product opened, sheath was bent, able to use for purpose of volume however not able to float swan ganz catheter.".

• Brand Name: PSI KIT: 9 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18594182
• Report Number: 9680794-2024-00093
• Device Sequence Number: 6594972
• Product Code: DYB
• UDI-Device Identifier: 00801902057952
• UDI-Public: 00801902057952
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/02/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: AK-09903-A
• Device Lot Number: 33F23B0516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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