MAUDE Adverse Event Report: MEDCOMP 14.5FX24CM HEMO-FLOW; HEMODIALYSIS CATHETER

Model Number HFS 24

Device Problem Insufficient Information (3190)

Patient Problems Hypoxia (1918); Respiratory Failure (2484); Low Cardiac Output (2501)

Event Date 07/24/2014

Event Type  Injury  

Event Description

During the catheter insertion procedure "care was taken to insert the dilator and sheath in the vein.This went in with no difficulty and immediately the wire was removed from the sheath with the dilator.The valve was held in locked position.At this point a sucking noise lasting around one second was heard at the sheath.Digital pressure over the valve placed and the catheter fed into the sheath immediately.The patient complained of feeling unwell immediately and the monitor noted a rapid drop in oxygen saturation from around 95% to well below 50% in one minute.The tear away sheath was removed after the catheter was fed into the correct position.The patient was turned onto the left position immediately.A medical emergency team (met) call was made.After the met arrived, the patient was bag ventilated and required resuscitation including intubation, cardiac compressions for low output and iv adrenaline.The catheter had a 20cc syringe attached and attempt made to aspirate air, but none was seen.He was successfully resuscitated and taken to icu." the patient recovered within 24 hours, no neurological complications from the event.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.The complaint was forwarded to the device manufacturing facility for review.The investigation included a review of the device history record (dhf).A review of the top assembly work order found no discrepancies for any abnormalities that may have caused the sheath to leak during use.All samples inspected met the 4cc/sec leak specification.The instructions for use state the product is not intended to create a complete two-way seal, is not a hemostatis device, and the valve will substantially reduce air intake, but at 12mm hg vacuum pressure the introducer may allow up to 4cc/sec of air to pass through the valve.The manufacturer was unable to confirm the cause of the failure as the device was not returned, and the investigation indicates the device met specification prior to shipment.

• Brand Name: 14.5FX24CM HEMO-FLOW
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp dr.; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp dr.; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4109789
• MDR Text Key: 4698985
• Report Number: 2518902-2014-00058
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2016
• Device Model Number: HFS 24
• Device Catalogue Number: HFS 24
• Device Lot Number: MGAA210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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): Life Threatening; Required Intervention