MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

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

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

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the spring wire guide could not be inserted into the introducer needle during the procedure because of resistance.A new kit was used instead.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported the spring wire guide could not be inserted into the introducer needle during the procedure because of resistance.A new kit was used instead.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one spring wire guide (swg), ars and lidstock for evaluation.Signs of use in the form of biological material were found on the swg.No needle was returned for evaluation.Visual inspection of the swg reveal three minor bends in the body.Microscopic examination confirmed the distal and proximal welds were present and spherical.Visual inspection was not able to be performed on the complaint introducer needle as one was not returned.The bends in the guide wire body measured 155 mm, 410 mm, and 574 mm, from the proximal end.The total length of the swg measured 603 mm, which is within specifications of 596-604 mm.The outer diameter of the swg measured 0.801 mm, which is within specifications of 0.788-0.826 mm per.The swg was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "advance swg into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned swg was able to pass through the returned ars and a lab inventory needle with no issues.Functional testing was not able to be performed on the complaint introducer needle as one was not returned.A manual tug test confirmed the distal and proximal welds were secure.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage." the complaint of swg/needle resistance was not able to be confirmed through a complaint investigation of the returned sample because the needle was not returned.The returned swg was found to have three minor bends in its body.Despite the damage, the swg was able to pass all relevant dimensional and functional testing.Based on the sample returned, a root cause could not be determined without the needle returned.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16006220
• MDR Text Key: 306928472
• Report Number: 3006425876-2022-01147
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F22C0618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED