MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN055207

Device Problem Unraveled Material (1664)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: physicians reports that the wire in the set has unraveled several times in the vessel.The entire device was removed from the vessel.A replacement device was used in the case successfully.Patient was reported as fine post the procedure.Complaint is associated to 1 reportable complaint 3006425876-2023-00966 and 1 non reportable complaint tc# (b)(4).

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.A review of the bill of materials for this product dating back 5 years did not reveal any changes to the guidewire component supplied within this kit.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: physicians reports that the wire in the set has unraveled several times in the vessel.The entire device was removed from the vessel.A replacement device was used in the case successfully.Patient was reported as fine post the procedure.Complaint is associated to 1 reportable complaint (b)(4) and 1 non reportable complaint tc# (b)(4).

• Brand Name: CVC SET: 3-LUMEN 7FR X 16CM
• 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: 17894067
• MDR Text Key: 325241375
• Report Number: 3006425876-2023-00965
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/13/2023

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 Operator: Health Professional
• Device Model Number: IPN055207
• Device Catalogue Number: EU-12703-N
• Device Lot Number: 71F20L3027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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