MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-06-28 for PDB1000 OMS-PDB1000 04572 manufactured by Guidant Corp Cardiac & Vascular Surgery Group Origin Medsystems, Inc..
[127267]
During a laparoscopic hernia repair, a pdb1000 popped. The surgeon had started the procedure and everything was proceeding without any complications. The pdb1000 was inserted into the pt and inflated with 40 pumps of air. A laparoscope was then inserted through the unit. The surgeon was going to wait approximately 2 minutes for hemostasis before continuing with the procedure. The balloon then popped before the 2 minute wait was completed. The surgeon then noticed a 4cm puncture in the bladder. The pdb1 was removed and inspected. The surgeon noticed a piece had detached from the unit. The piece that had detached from the balloon was then retrieved. The case was then converted to an open procedure to repair the bladder. The pt was last reported to be in satisfactory condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939738-1999-00020 |
| MDR Report Key | 229907 |
| Report Source | 05,06 |
| Date Received | 1999-06-28 |
| Date of Report | 1999-05-19 |
| Date of Event | 1999-05-19 |
| Date Facility Aware | 1999-05-19 |
| Report Date | 1999-05-19 |
| Date Mfgr Received | 1999-05-19 |
| Date Added to Maude | 1999-07-06 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDB1000 |
| Generic Name | PREPERITONEAL DISTENTION BALLOON SYSTEM |
| Product Code | FGY |
| Date Received | 1999-06-28 |
| Model Number | OMS-PDB1000 |
| Catalog Number | 04572 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 222971 |
| Manufacturer | GUIDANT CORP CARDIAC & VASCULAR SURGERY GROUP 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. Required No Informationntervention | 1999-06-28 |