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 1997-10-31 for STARGATE PENI FALLOPOSCOPY CATHETER RMSBES0007 NA manufactured by Conceptus, Inc..
[113890]
During a falloposcopy procedure in a hysterectomy patient the clear distal section of the stargate peni catheter and the catheter wire tip separated from the distal catheter shaft. The catheter was removed from the patient prior to the end of the procedrue. The distal clear section of the catheter and the catheter's wire tip were recovered from the patient's uterus post-hysterectomy. This adverse event is marked other because it is unknown as to whether or not this event would have resulted in permanent impairement of body function or damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1997-00006 |
| MDR Report Key | 129478 |
| Report Source | 01,05,06 |
| Date Received | 1997-10-31 |
| Date of Report | 1997-10-30 |
| Date of Event | 1997-10-01 |
| Date Mfgr Received | 1997-10-01 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1997-11-04 |
| 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 | MA |
| 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 | 1997-10-31 |
| 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 | 126648 |
| 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 | 1997-10-31 |
| 2 | 0 | 1997-10-31 |