MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-20 for * RPC-9PU manufactured by Life-tech Inc.
[332140]
Rectal catheter was removed after procedure, nurse noticed that balloon to catheter was missing. Nurse informed dr who examined pt. No balloon found.
Patient Sequence No: 1, Text Type: D, B5
[21715475]
Add'l info rec'd from mfr 8/12/03: no failure analysis or lab testing could be performed on the device listed in the report. Since life-tech was never directly informed of this event by the user facility, director of ra spoke with the individual who reported the event on 07/23/03. They stated that the device was in their possession in a box that, since facility had recently relocated, they would have to locate it. They stated thet would locate it by early the following week and call director back. Director attempted to contact them on 7/31, leaving a verbal message requesting that they contact them, and then again this morning, leaving the same type of message. In neither instance was director contacted. Departures from routine procedures for use and removal of an rpc-9pu rectal pressure catheter can adversely impact the balloon. Overfilling of the balloon during use can result in overstressing of the bond between the balloon and the catheter. Removal of the catheter from the rectum prior to complete deflation can result in the application of excess force to the balloon-catheter bond. Either of these procedural variables can weaken the bond between the balloon and the catheter to such an extent as to make the balloon come off the catheter. A review of complaints for this product for the past two years show the extremely low occurrence of this type of event: for 2001, it was reported twice (0. 003%); for 2002, it was reported 11 times (0. 0131%). The unusually rare occurrence of this type of event strongly insinuates that the event is not attributable to the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028685 |
| MDR Report Key | 465795 |
| Date Received | 2003-05-20 |
| Date of Report | 2003-05-16 |
| Date of Event | 2003-05-06 |
| Date Added to Maude | 2003-06-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ABDOMINAL PRESSURE CATHETER 9F |
| Product Code | GBT |
| Date Received | 2003-05-20 |
| Model Number | RPC-9PU |
| Catalog Number | * |
| Lot Number | 4C21703 |
| ID Number | * |
| Device Expiration Date | 2005-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 454739 |
| Manufacturer | LIFE-TECH INC |
| Manufacturer Address | 4235 GREENBRIAR STANFORD TX 774773995 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-20 |