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

Model Number	IPN000153
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
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).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.
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).The customer returned multiple components of a psi kit, including one dilator and sheath for analysis.The dilator hub was not returned for analysis.Definite signs of use were observed in the form of biomaterial.Visual analysis of the dilator separation point revealed that it was rough and discolored.The condition of the separation point appeared to be 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 not within the specification limits of 28 3/4" - 29 1/4" per the dilator product drawing.The overall length of the sheath measured 18" which is not within the specification limits of 25" - 26" per the sheath product drawing.Due to the discrepancy between the measurements of the returned device and the reported material, the customer report cannot be confirmed at this time.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.Visual analysis revealed that the dilator was separated, and the separation point was rough and discolored.The appearance of the damage is consistent with dilator damage within the scope of a previously opened capa.However , without the dilator hub returned and due to the dimensional discrepancy between the returned device and reported material, the potential root cause cannot be confirmed.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: 17132211
• Report Number: 9680794-2023-00407
• Device Sequence Number: 15067355
• Product Code: DQY
• UDI-Device Identifier: 00801902002013
• UDI-Public: 00801902002013
• 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: IPN000153
• Device Catalogue Number: CL-07865
• Device Lot Number: 14F22C0041
• 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: 03/12/2022
• 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