MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ACCESS TRAY; WIRE GUIDE CATHETER

Model Number IPN000017

Device Problem Obstruction of Flow (2423)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Event Description

It was reported that the sheath could not be flushed through the extension with the side port.During sheath advancement in the patient's artery there was no back flow of blood from the artery to the extension line.Doctor used a syringe to try and draw the blood but was unsuccessful.As a result, a new kit was used successfully.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the sheath could not be flushed through the extension with the side port.During sheath advancement in the patient's artery there was no back flow of blood from the artery to the extension line.Doctor used a syringe to try and draw the blood but was unsuccessful.As a result, a new kit was used successfully.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).The product was not returned for investigation.The reported complaint for the "sheath could not be flushed through the extension" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

It was reported that the sheath could not be flushed through the extension with the side port.During sheath advancement in the patient's artery there was no back flow of blood from the artery to the extension line.Doctor used a syringe to try and draw the blood but was unsuccessful.As a result, a new kit was used successfully.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Returned for investigation was a dilator and sheath from a 6fr transradial artery access kit with the original packaging.The reported lot number (71f21d1888) matches the lot number on the returned packaging.Returned with the sample were the supplied spring-wire guide (swg) and needle; no damage or abnormalities were noted to the components.Upon visual inspection, the sheath hub and sheath tip appeared typical.No blood was noted on the sheath.No visual blockages in the sheath sidearm were noted.The returned dilator was visually inspected; the dilator hub and tip appeared typical.Some dried blood was noted within the dilator.The sheath sidearm was aspirated and flushed using a 60cc lab-inventory syringe without difficulty; no blockage, blood or debris was noted.The sheath was inserted into the t-tube and the t-tube was pressurized to 200mmhg.No leaks were detected from the sheath.The dilator was aspirated and flushed successfully.Some dried blood was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "sheath could not be flushed through the extension with the side port" is not confirmed.During the investigation, no blockage was found, and the sheath was flushed without difficulty from the sheath sidearm.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.

• Brand Name: ACCESS TRAY
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13666910
• MDR Text Key: 289452746
• Report Number: 3010532612-2022-00050
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902002426
• UDI-Public: 00801902002426
• Combination Product (y/n): N
• Reporter Country Code: WA
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: IPN000017
• Device Catalogue Number: AA-15611-S
• Device Lot Number: 71F21D1888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 110 KG