MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-01-14 for ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET WOGS-1200 manufactured by Cook Inc..
[21781456]
The physician stated that a hole from the tube was outside of the pt's stomach when the pt was fed in the ward. He said that upon initial insertion and contrast check, the pigtail loop was definitely inside the stomach and that there were no problems with the locking mechanism that would cause the tube to come out of the stomach. In between the time that the pt was being diagnosed with peritonitis and going to theatre, the pt came to their x-ray dept for a ct scan. Dr said it appeared that the loop seemed to be smaller than usual (ie approximately 2cm in diameter and not 3cm in diameter). He said that these were his estimates on what it looked like and what it normally looks like. These ct images are not available. We were advised that the tube was then pushed further into the stomach by the radiologist, and the pt is continuing to be fed through the same tube with no problems. Dr stated that the pt is a large man who coughed "very vigorously. " pt developed peritonitis when liquid food was given via the gastrostomy tube. Was taken to theatre for laparoscopic surgery and washout. Pt was admitted to intensive care unit and remains in intensive care, but is improving.
Patient Sequence No: 1, Text Type: D, B5
[21829300]
No product was received to assist in our investigation; therefore, we are unable to determine with certainty the root cause for the reported difficulty. However, we can advise this device is verified 100% that the catheter tubing is the correct type and appropriate diameter, prior to further processing. It is also verified to be clean, smooth and void of excessive dents. The provided info for use (ifu) details proper placement and usage technique. We will continue to monitor this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2009-00012 |
| MDR Report Key | 1291614 |
| Report Source | 01,05,08 |
| Date Received | 2009-01-14 |
| Date of Report | 2008-12-22 |
| Date of Event | 2008-12-04 |
| Date Facility Aware | 2008-12-04 |
| Report Date | 2008-12-22 |
| Date Mfgr Received | 2008-12-22 |
| Device Manufacturer Date | 2008-06-06 |
| Date Added to Maude | 2009-01-28 |
| 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 | RITA HARDEN, MGR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET |
| Generic Name | EZK CATHETER, RETENTION TYPE |
| Product Code | EZK |
| Date Received | 2009-01-14 |
| Model Number | NA |
| Catalog Number | WOGS-1200 |
| Lot Number | 2097128 |
| ID Number | NA |
| Device Expiration Date | 2011-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-14 |