MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920486
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the insertion of the introducer, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent." no patient harm was reported.A new device was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the insertion of the introducer, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent." no patient harm was reported.A new device was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire for analysis.The dilator(s) involved with this complaint were not returned for analysis.No definite signs of use were observed.Visual analysis revealed one major kink and two slight bends on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the dilator(s) involved with this complaint as they were not returned for analysis.The kink in the guide wire measured 743mm from the proximal weld.The guide wire length measured 100.6mm, which is within the specification limits of 98.75cm-101.25cm per the guide wire product drawing.The guide wire outer diameter measured.0375", which is within the specification limits of.0370"-.0385" per the guide wire product drawing.A manual tug test confirmed that the distal and proximal welds were secure and intact.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, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one major kinks on the guide wire.The guide wire also met all relevant dimensional requirements.Despite this, visual, dimensional, and functional analysis could not be performed on the dilators as they were not returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 15974440
• Report Number: 9680794-2022-00771
• Device Sequence Number: 5705604
• Product Code: MSD
• UDI-Device Identifier: 10801902195248
• UDI-Public: 10801902195248
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: IPN920486
• Device Catalogue Number: CS-15272-VFE
• Device Lot Number: 13F21M0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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
• Patient Sex: Unknown