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

Model Number	IPN000152
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components of a psi kit, including one dilator and sheath, for analysis.Definite signs of use in the form of biomaterial were observed.Visual analysis revealed that the dilator hub was completely separated from the dilator body.The separation point was rough and discolored.The condition of the separation point appeared consistent to that of a stress related break.No other defects or anomalies were observed.The overall length of the dilator measured 21" which is within the specification limits of 20 7/8" - 21 3/8" per the dilator product drawing.This indicates that the separation points likely occurred directly adjacent to the dilator luer hub.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 separation point appeared rough and discolored.Despite this, the dilator met all relevant dimensional requirements.The appearance of the dilator separation is consistent with the damage within the scope of a previously opened capa.However, without the dilator hub returned for analysis, the potential root cause cannot be confirmed.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported the dilator tip was found damaged during use on the patient.No patient harm was reported.The patient's condition is reported as fine.

• 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: 17132210
• Report Number: 9680794-2023-00406
• Device Sequence Number: 6458098
• Product Code: DQY
• UDI-Device Identifier: 00801902002006
• UDI-Public: 00801902002006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023

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: IPN000152
• Device Catalogue Number: CL-07845
• Device Lot Number: 14F22D0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 08/03/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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.; NOT REPORTED.
• Patient Sex: Unknown