MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number PR-05041

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

As reported on (b)(6) 2022 during a picc insertion for the administration of intravenous daptomycin , "initial venous access is obtained and advanced needle, then advanced guidewire on the flexible side not being able to advance.When removing the guide, it was crooked, the guidewire is advanced on the non-flexible side." no medical intervention was needed.It was reported that there was no patient harm.The current patient's condition is fine.

Manufacturer Narrative

(b)(4).The customer returned one nitinol guide wire in its protective tubing for analysis.The guide wire was kinked and showed evidence of use.The needle was not returned.Visual inspection of the guide wire revealed multiple kinks and bends towards the distal end of the guide wire.Microscopic examination confirmed the damage.The distal weld was present and no evidence of unraveling was observed.Visual inspection of the needle could not be performed as it was not returned for analysis.The major kinks in the guide wire measured 14mm, 55mm, and 96mm from the distal tip.The guide wire total length measured 455mm, which is within the specifications of 437.5mm-462.5mm per product drawing.The guide wire outer diameter measured 0.01800", which is within the specifications of 0.0160"-0.0185" per product drawing.Functional inspection of the guide wire was performed per the product instructions for use, which states "insert floppy tip of spring-wire guide through introducer needle into vein.Advance spring-wire guide in routine fashion to desired depth." the guide wire was threaded through a lab inventory 21 ga needle.The guide wire was able to pass completely through the needle with minimal resistance.A manual tug test confirmed the distal weld was secure on the guide wire.A device history record review was performed, and the following findings were identified: for material r-05052-006, two non-conformances were initiated for 14p16l0022 with regards to an improper cleaning procedure.Given that the damage occurred during use, these findings are unlikely to have contributed to the damage observed.The instructions for use (ifu) provided with this kit warns the user, "warning: do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed multiple kinks towards the distal end of the guide wire.The returned guide wire met all relevant dimensional and functional requirements.The customer report of guide wire/needle resistance could not be confirmed without the needle returned for analysis.Based on these circumstances, and without the complete sample returned, the probable root cause for this event could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

As reported on (b)(6) 2022 during a picc insertion for the administration of intravenous daptomycin , "initial venous access is obtained and advanced needle, then advanced guidewire on the flexible side not being able to advance.When removing the guide, it was crooked, the guidewire is advanced on the non-flexible side." no medical intervention was needed.It was reported that there was no patient harm.The current patient's condition is fine.

• Brand Name: ARROW PICC SET: 4 FR X 19-1/2" (50 CM)
• Type of Device: CATHETER, INTRAVASCULAR, THER
• 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: 15541255
• MDR Text Key: 305840945
• Report Number: 9680794-2022-00629
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: PR-05041
• Device Lot Number: 14F21H0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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
• Treatment: INTRAVENOUS DAPTOMYCIN.; INTRAVENOUS DAPTOMYCIN.
• Patient Age: 35 YR
• Patient Sex: Female