MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 15CM DUO-FLOW 400XL IJ; ST HEMODIALYSIS CATHETER

Model Number DFXL146IJSE

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is ongoing.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Three separate attempts were made to insert a catheter in the same patient.First attempt was an ultrasound-guided insertion of the jugular pre-curved hemodialysis catheter.At the time of needle removal, with the guidewire in the patient's vein, deformity and resistance of the guidewire is observed, which causes loss of cannulation.A new insertion is attempted.The second attempt was an ultrasound-guided insertion of jugular pre-curved hemodialysis catheter.Once the vein is cannulated at the time of withdrawing the dilator, it generates deformation in the guidewire, produces curvature in the guide structure.A new insertion is attempted.The third attempt was another ultrasound-guided insertion of femoral straight hemodialysis catheter.When the guidewire was going to be removed with the catheter already in the patient's vein, the guidewire unravels losing its structure, the catheter is completely withdrawn.

Manufacturer Narrative

None of the devices for this complaint were returned for evaluation.Photographs provided indicate the guidewires had become stuck in the insertion needle.The condition of the guidewires in the photographs suggest they were subjected to forces greater than they are designed to withstand, resulting in unraveling of the wire.The photograph of the dilator shows a kink approximately half-way down the shaft and the tip is bent with a slight burr at the very tip.This is indicative of the guidewire being snagged and pulled back on the dilator tip.The contract manufacturer of each device conducted a review of the manufacture records for the lot numbers reported.Their investigations revealed the devices were manufactured, inspected, and packaged according to specification with no non-conformances or abnormalities.A root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) contains the following warnings and precautions: do not advance the guidewire or catheter if unusual resistance is encountered.Do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the catheter and guidewire must be removed together.When introducer needle is used, do not withdraw guidewire against needle bevel to avoid possible severing of guidewire.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 14F X 15CM DUO-FLOW 400XL IJ
• Type of Device: ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16136771
• MDR Text Key: 307072362
• Report Number: 2518902-2023-00003
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DFXL146IJSE
• Device Catalogue Number: DFXL146IJSE
• Device Lot Number: MQLN830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 120 KG