MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-44052-VPS2

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported "stylet was bent upon removal from packaging".The user noticed it was bent, but used it on the patient.It was reported "it worked and it was placed, but it didn't work well".No patient harm reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "stylet was bent upon removal from packaging".The user noticied it was bent, but used it on the patient.It was reported "it worked and it was placed, but it didn't work well".No patient harm reported.

Manufacturer Narrative

Qn# (b)(4).The customer returned one guide wire for analysis.Signs of use were observed on the guide wire, which matches the customer report that kinking/bending was observed prior to use but was proceeded to be used on the patient.Visual analysis revealed that the guide wire was kinked on the coiled, distal end.Microscopic examination confirmed the kinking.During normal assembly with a lab inventory tubing, the kinking would have been located within the blue advancer/straightener tubing, protecting it from damage.The kink in the guide wire measured 36mm from the distal weld.The guide wire total length measured 45.1cm which is within the specification limits of 43.75cm-46.25cm per the guide wire product drawing.The guide wire outer diameter measured.0180" which is within the specification limits of.0160"-.0185" per the guide wire product drawing.A manual tug test confirmed that the coiled end of the guide wire was secure and intact.The purchasing facility was contacted as part of this complaint investigation.They indicated that the purchased guide wire is 100% inspected for damage during the assembly process.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 if package is damaged".The report that the spring wire guide was kinked was confirmed through visual examination of the returned sample.One kink was observed on the guide wire body.The guide wire met all relevant dimensional requirements.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.During normal assembly, the kinked portions of the guide wire would have been located inside the tubing assembly, protecting it from damage.Between this and the comments from the purchasing facility, it cannot be confirmed when the guide wire became kinked.Therefore, the root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 14804153
• MDR Text Key: 295967106
• Report Number: 9680794-2022-00408
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/08/2022

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: 06/30/2023
• Device Catalogue Number: CDC-44052-VPS2
• Device Lot Number: 13F22B0402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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