MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-11-10 for ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET WOGS-1200 manufactured by Cook Inc.
[1757717]
The wogs-1200 was implanted on friday the 08th of october and the medical facility send the pt back to the other hospital. There the pt got "ill" on saturday the 09th of october. On sunday the 10th, they made a emergency operation because of peritonitis. On tuesday the 12th, the pt expired. The customer told the rep what has happened with the following info: during the procedure, everything was fine. They sent the pt back to the other hospital. In this other hospital they manipulated the catheter, pulling the catheter out of the body of the pt until the first sidehole was seen. They then pushed it back into the pt. They did not know this "new" product, so the customer thinks this was a handling failure.
Patient Sequence No: 1, Text Type: D, B5
[8901023]
Pt code: peritonitis and death/expired is not addressed in the ifu. Use of this device is provided in the ifu. No product was returned. An ifu is provided, in which it is stated: "do not withdraw the loop so far that it begins to enter the gastrostomy tract; doing so may result in withdrawal of catheter sideholes into the tract, and is not necessary for apposition of the stomach to the abdominal wall. Use fluoroscopy to facilitate proper positioning of the catheter loop. " in the info provided, the customer states, "in this other hospital they manipulated the catheter, so they pulled the catheter out of the body until the first side hole was seen, then they pushed it back into the pt. " the sideport that the customer describes seeing is located within the locking loop. Therefore, in order to view this sidehole, the catheter had to have been in a unlocked position. It is possible that after pulling a portion of this catheter out, the catheter unlocked and was not properly replaced back into the pt's stomach. This is likely what led to the pt developing peritonitis. We will continue to monitor for similar devices and have notified the appropriate personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2010-00552 |
| MDR Report Key | 1899947 |
| Report Source | 01,08 |
| Date Received | 2010-11-10 |
| Date of Report | 2010-10-13 |
| Date of Event | 2010-10-08 |
| Date Facility Aware | 2010-10-13 |
| Report Date | 2010-10-13 |
| Date Mfgr Received | 2010-10-13 |
| Device Manufacturer Date | 2010-05-13 |
| Date Added to Maude | 2010-11-18 |
| 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, MANAGER |
| 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 | 2010-11-10 |
| Model Number | NA |
| Catalog Number | WOGS-1200 |
| Lot Number | F2505100 |
| ID Number | NA |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 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. Death | 2010-11-10 |