MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 1998-06-29 for PREPERITONEAL DISTENTION BALLOON OMS-PDB1000 04572 manufactured by Origin Medsystems, Inc..
[100096]
It was reported that during a laparoscopic hernia procedure, a pt's bladder suffered a tear. The info received indicates that the balloon was inflated with the allowable maximum of 40 pumps. The balloon then allegedly popped and fractured into two pieces. After the unit and the dislodged pieces were removed from the pt, the surgeon noticed the pt had a 1 inch hole in the bladder. The hole in the bladder was successfully closed. The dr and nurse reported to the sales rep that the pt was almost conscious during the procedure. A nurse present during the case commented to the dr that the anesthesiologist had not properly sedated the pt for a laparoscopic technique procedure. The dr made a comment, indicating that the unit had functioned as intended, but believes that the reason the balloon popped was due to the pt not being properly anesthetized. The dr reported that the pt showed some discomfort through facial gestures, thus causing the pt's inner wall and organs to react to the pain. This is believed to have put some pressure on the balloon, therefore possibly popping it. The pt is reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939738-1998-00007 |
| MDR Report Key | 175149 |
| Report Source | 05,06,08 |
| Date Received | 1998-06-29 |
| Date of Report | 1998-05-29 |
| Date of Event | 1998-05-29 |
| Date Mfgr Received | 1998-05-29 |
| Date Added to Maude | 1998-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPERITONEAL DISTENTION BALLOON |
| Generic Name | PREPERITONEAL DISTENTION BALLOON |
| Product Code | FGY |
| Date Received | 1998-06-29 |
| Model Number | OMS-PDB1000 |
| Catalog Number | 04572 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 170301 |
| Manufacturer | ORIGIN MEDSYSTEMS, INC. |
| Manufacturer Address | 135 CONSTITUTION DR. MENLO PARK CA 94025 US |
| Baseline Brand Name | PREPERITONEAL DISTENTION BALLOON |
| Baseline Generic Name | DISTENTION BALLOON |
| Baseline Model No | OMS-PDB1000 |
| Baseline Catalog No | OMS-PDB1000 |
| Baseline ID | NA |
| Baseline Device Family | PREPERITONEAL DISTENTION BALLOON |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K935426 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-06-29 |