MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1997-10-30 for STARGATE PENI FALLOPOSCOPY CATHETER RMSBES0007 NA manufactured by Conceptus, Inc..
[100587]
The stargate (tm) peni falloposcopy catheter was used during a falloposcopy procedure. After removing the catheter the physician noticed that the short cage wires had become dislodged from the stargate peni falloposcopy catheter. The device was easily withdrawn from the pt. The physician believed that the wire dislodgment may have occurred in the coaxess (tm) catheter and not in the pt's tube. This adverse event is marked other because it is unk as to whether or not this event resulted in any permanent impairment of body function or damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1997-00005 |
| MDR Report Key | 130151 |
| Report Source | 01,05,06 |
| Date Received | 1997-10-30 |
| Date of Report | 1997-10-30 |
| Date of Event | 1997-09-30 |
| Date Mfgr Received | 1997-09-30 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1997-11-06 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STARGATE PENI FALLOPOSCOPY CATHETER |
| Generic Name | FALLOPIAN TUBE CATHETER |
| Product Code | MKO |
| Date Received | 1997-10-30 |
| Returned To Mfg | 1997-10-09 |
| Model Number | RMSBES0007 |
| Catalog Number | NA |
| Lot Number | RD9713201 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 127292 |
| Manufacturer | CONCEPTUS, INC. |
| Manufacturer Address | 1021 HOWARD AVE. SAN CARLOS CA 94070 US |
| Baseline Brand Name | STARGATE PENI FALLOPOSCOPY CATHETER |
| Baseline Generic Name | FALLOPIAN TUBE CATHETER |
| Baseline Model No | RMSBES0007 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-30 |