MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. SKATER¿ DRAINAGE CATHETER; DRAINAGE CATHETERS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemothorax (1896); Hypovolemic Shock (1917)

Event Date 03/14/2019

Event Type  Death  

Manufacturer Narrative

Neither a part number nor a lot number were provided, so a review of device batch records could not be conducted.The device was not returned for evaluation.There are no indications that the drainage catheter device malfunctioned or caused the event.The event description states that the drainage catheter had an "uncomplicated admission and drainage were well-functioning".Also, the event description states "no one keep point so far that this is contingent in equipment failure." communication with argon's director of global clinical services and physician education stated "if the patient went into hemorrhagic shock and cardiac failure due to hemothorax that would most likely be caused by transecting the intercostal artery during placement of the skater drain.That would have nothing to do with the product and would be due to placement technique/ technical error." as no sample was returned and the root cause could not be determined, no corrective action will be taken in response to this complaint.Additionally, it is likely that the event was due to placement technique/ technical error (per clinical input based on the provided event description).

Event Description

The patient was admitted to the (b)(6) on (b)(6) 2019 due to clinically important pleural fluid.Usual procedure followed.Uncomplicated admission and drainage were well-functioning for the patient to autoseparate this.This bell quickly discovered and action taken.The patient then went fast in shock and died despite attempted revival.Supposed bleeding shock due to hematothorax, but this is not confirmed.Police and health inspectorate notified.Results of legal autopsy are not known.No one keep point so far that this is contingent in equipment failure.

• Brand Name: SKATER¿ DRAINAGE CATHETER
• Type of Device: DRAINAGE CATHETERS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 8577640
• MDR Text Key: 143964486
• Report Number: 1625425-2019-00120
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): Y
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death