MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6IN (16 CM); CATHETER PERCUTANEOUS

Catalog Number	ES-04706
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the swg kinked when swg insertion into ars, dilator tip was found blunt during use on the patient.They changed to a new one." there was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr includes: 3006425876-2024-01137.
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the swg kinked when swg insertion into ars, dilator tip was found blunt during use on the patient.They changed to a new one." there was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr includes:3006425876-2024-01137.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit containing multiple components for analysis.The guide wire, arrow raulerson syringe (ars), and introducer needle will be analyzed as part of this com-plaint.No definite signs-of-use were observed.Visual analysis revealed one kink/bend towards the distal j-bend.This resulted in the j-bend to be slightly misshapen.Microscopic examination con-firmed the damage and revealed that the distal and proximal welds were full and spherical.The kinks on the guide wire measured 430mm from the proximal weld.The guide wire total length measured 456mm, which is within the s pecification limits of 450mm-458mm per the guide wire prod-uct drawing.The guide wire outer diameter measured 0.790mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The kinks on the guide wire meas-ured 430mm from the proximal weld.The guide wire total length measured 456mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.790mm, which is within the specification limits of 0.788mm-0.826mm 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.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 analysis of the returned sample.Visual analysis of the guide wire revealed kinking across the body.Despite the damage, all relevant di-mensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 14 GA X 6IN (16 CM)
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20641555
• Report Number: 3006425876-2024-01084
• Device Sequence Number: 20705038
• Product Code: DQY
• UDI-Device Identifier: 00801902108418
• UDI-Public: (01)00801902108418(11)230815(17)280731(10)71F23H0798(21)
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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 Catalogue Number: ES-04706
• Device Lot Number: 71F23H0798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown