MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for APIG1260T] SKATER TRAY 6F PIG manufactured by Argon Medical Devices.
[51015086]
The lot number was not provided; therefore,the device history record could not be reviewed. There was no patient injury. The complaint device was not returned for analysis; therefore, the precise root cause of the complaint could not be determined. The ifu states to verify the integrity of the catheter components before use. If a component appears damaged, use a replacement catheter. The skater? Safety centesis catheter with pigtail and blunt retracting stylet is intended for aspiration of fluid from the body. In thoracentesis, the fluid is removed from the pleural cavity. It is probable that the device was placed too close to a rib and the breathing of the patient caused kinking of the catheter which required hand pumping of the fluid by the physician.
Patient Sequence No: 1, Text Type: N, H10
[51015087]
The pigtail catheter was inserted into thora drainage space using standard technique. The catheter was close to a rib. The breathing of the patient caused kinking in the catheter preventing flow. The fluid had to be hand pumped by the doctor in between each respiration to complete the drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2016-00036 |
| MDR Report Key | 5812179 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-07-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APIG1260T] SKATER TRAY 6F PIG |
| Generic Name | SKATER TRAY 6F PIG |
| Product Code | GBQ |
| Date Received | 2016-07-21 |
| Catalog Number | APIG1260T |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-21 |