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

Model Number	IPN920042
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after introducing the super arrow-flex sheath over the guidewire, the physician tried to remove the stylet.The stylet broke and stayed in the sheath.The sheath was then carefully removed, including the tip of the stylet.The patient was not harmed." a new sheath of a a different brand was used.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after introducing the super arrow-flex sheath over the guidewire, the physician tried to remove the stylet.The stylet broke and stayed in the sheath.The sheath was then carefully removed, including the tip of the stylet.The patient was not harmed." a new sheath of a a different brand was used.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cath-lab sheath set, including one dilator, sheath, and product lidstock , for analysis.Definite signs of use were observed.Visual analysis revealed that the dilator hub was completely separated from the dilator body.No remains of the dilator were observed within the hub.Adhesive was observed at the location of the separation on both the dilator body and within the dilator hub cavity.The outer diameter of the dilator measured 0.0835" which is within the specification limits of 0.082" - 0.085" per the dilator extrusion graphic.A device history record review was performed and no relevant findings were identified.The customer report of a dilator hub separation was confirmed through investigation of the returned sample.The dilator body completely separated from the hub with no remains of the dilator within the hub.Despite this, the dilator passed relevant dimensional requirements and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• 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: 17719556
• Report Number: 9680794-2023-00647
• Device Sequence Number: 17898108
• Product Code: DQY
• UDI-Device Identifier: 00801902001849
• UDI-Public: 00801902001849
• 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): 08/16/2023

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 Model Number: IPN920042
• Device Catalogue Number: CL-07635
• Device Lot Number: 14F23A0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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