MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-05-03 for SKATER? DRAINAGE CATHETER UNK manufactured by Argon Medical Devices Inc..
[143964486]
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).
Patient Sequence No: 1, Text Type: N, H10
[143964487]
The patient was admitted to the perandren (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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2019-00120 |
| MDR Report Key | 8577640 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-14 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER? DRAINAGE CATHETER |
| Generic Name | DRAINAGE CATHETERS |
| Product Code | GBQ |
| Date Received | 2019-05-03 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-03 |