MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL; INTRODUCER, CATHETER

Catalog Number CDC-29903-XCN1A

Device Problem Material Deformation (2976)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the user was unable to advance the catheter/dilator past the catheter and noted the end of the catheter was irregular and "frayed".The user was able to leave the wire in and obtain a new catheter that appeared normal and was easily placed.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer provided one photo as part of this investigation.Visual analysis revealed that the sheath tip was slightly frayed.Signs of use were also observed.The customer also returned one sheath/dilator assembly for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed that the sheath tip was slightly frayed.Microscopic examination confirmed the damage and revealed white stress marks around the frayed area.This defect is consistent with damage due to undue force applied during insertion.The sheath length from the juncture hub to the distal tip measured 4 1/4", which is within the specification limits of 4"-4 1/4" per the sheath product drawing.The sheath tip inner diameter measured.118", which is within the specification limits of.117"-.118" per the sheath product drawing.The returned dilator was removed and reinserted through the valve end of the sheath.The dilator was able to pass through the sheath extrusion with little to no difficulty.Performed per ifu statement , "insert entire length of dilator through hemostasis valve into sheath pressing hub of dilator firmly into hub of hemostasis valve assembly.Place assembly on sterile field awaiting final sheath placement".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The ifu also states, "do not withdraw dilator until the sheath is well within the vessel to reduce the risk of damage to sheath tip".The report of a damage sheath tip was confirmed through complaint investigation.Visual analysis of the sample revealed that the sheath tip was slightly frayed.Despite the damage, all relevant dimensional 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.

Event Description

It was reported the user was unable to advance the catheter/dilator past the catheter and noted the end of the catheter was irregular and "frayed".The user was able to leave the wire in and obtain a new catheter that appeared normal and was easily placed.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
• 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: 15108515
• MDR Text Key: 302122784
• Report Number: 9680794-2022-00455
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940079
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Catalogue Number: CDC-29903-XCN1A
• Device Lot Number: 13F22D0558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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