MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS; INTRODUCER, CATHETER

Model Number IPN911881

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the spring wire guide unraveled.No patient harm reported.The patient's condition is reported as fine.

Event Description

Customer reported the spring wire guide unraveled.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned a single guide wire for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have one kink towards the proximal end of the body.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The guide wire was not unraveled as the customer reported.The design of the returned guide wire does not match the design of the guide wire supplied in the customer reported kit number.The reported guide wire part is a nitinol design with a solid core proximal end and the returned guide wire is coiled throughout.This indicates that either the incorrect guide wire was returned, or the incorrect product code was reported by the customer.The kink in the guide wire was measured at 11mm from the proximal weld.The overall length of the guide wire measured 45.60cm which is within the specification of 43.75-46.25cm per guide wire product drawing.The outer diameter of the guide wire measured 0.0235" which is not within the specification limit of 0.0160-0.0185" per guide wire product drawing.This further supports that either the incorrect guide wire was returned, or the incorrect product code was reported by the customer.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.Major resistance was observed at the kinking; however, the undamaged portion of the guide wire was able to pass as expected.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire kinked during use was confirmed through examination of the returned sample.Visual examination revealed that the guide wire was kinked towards the proximal weld.The returned guide wire design and outer diameter did not match the guide wire supplied in the customer reported kit number , indicating that either the incorrect sample was returned, or the incorrect product code was reported by the customer.A device history record review performed on the reported kit did not identify any relevant findings.However, the probable cause of guide wire damage could not be determined based on the discrepancy between the customer reported kit number and the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS
• Type of Device: INTRODUCER, CATHETER
• 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: 13580634
• MDR Text Key: 285997520
• Report Number: 9680794-2022-00102
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902134988
• UDI-Public: 10801902134988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN911881
• Device Catalogue Number: ASK-45541-VFH
• Device Lot Number: 13F21K0734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1