MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDA-45703-P1A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the guide did not fit with the catheter" during insertion.A new product was used.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen catheter for evaluation.The guide wire was not returned.Visual examination did not reveal any defects or anomalies on the returned catheter.Visual inspection of the guide wire could not be performed as the guide wire was not returned.The catheter body length from the juncture hub to the distal tip measured 217mm, which is within the specification limits of 216.9-217.1mm per the catheter product drawing.The catheter body outer diameter measured 0.09750", which is within the specification limits of 0.094"-0.098" per the catheter extrusion product drawing.A lab inventory 0.032" guide wire was inserted through the distal end of the returned catheter.The guide wire was able to advance through the catheter with little to no resistance.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".Functional inspection could not be performed on the reported guide wire as it was not returned.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation and bleeding.Do not apply excessive force in removing guidewire or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested.".The customer report of a kinked guide wire could not be confirmed based on evaluation of the returned sample.A complete visual inspection could not be performed as the guide wire was not returned and no defects or anomalies were observed with the returned catheter.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the guide wire being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the guide did not fit with the catheter" during insertion.A new product was used.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 17492218
• Report Number: 9680794-2023-00599
• Device Sequence Number: 7246331
• Product Code: FOZ
• UDI-Device Identifier: 00801902099471
• UDI-Public: 00801902099471
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071538
• 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
• Report Date (Section B): 07/13/2023

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 Expiration Date: 09/21/2024
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 13F23A0221
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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