MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-04-23 for COAXESS CATHETER VS FALLOPOSCOPY CATHETER/GUIDEWIRE SLU003 VSC002/GUI007 NA manufactured by Conceptus, Inc..
[16029153]
Adverse event: during a falloposcopy procedure the physician perforated a fallopian tube at the tubal ostium. This is an anticipated adverse event as indicated in the product labeling. No medical intervention was required to resolve the adverse event and there was no clinical sequelae. *the adverse event is marked "other" because it is unknown as to whether or not the adverse event will result in permanent impairment of body function or permanent damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1998-00001 |
| MDR Report Key | 164390 |
| Report Source | 05,07 |
| Date Received | 1998-04-23 |
| Date of Report | 1998-04-22 |
| Date of Event | 1998-04-01 |
| Date Mfgr Received | 1998-04-09 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1998-04-28 |
| 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 | COAXESS CATHETER VS FALLOPOSCOPY CATHETER/GUIDEWIRE |
| Generic Name | UTERINE CATHETER FALLOPIAN TUBE CATHETER/GUIDEWIRE |
| Product Code | MKO |
| Date Received | 1998-04-23 |
| Model Number | SLU003 VSC002/GUI007 |
| Catalog Number | NA |
| Lot Number | C02123 C02073/C02048 |
| ID Number | NA |
| Device Expiration Date | 2000-08-01 |
| 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 | 160015 |
| Manufacturer | CONCEPTUS, INC. |
| Manufacturer Address | 1021 HOWARD AVE. SAN CARLOS CA 94070 US |
| Baseline Brand Name | COAXESS CATHETER VS FALLOPOSCOPY CATHETER/GUIDEWIRE |
| Baseline Generic Name | UTERINE CATHETER FALLOPIAN TUBE CATHETER/GUIDEWIRE |
| Baseline Model No | SLU003 VSC002/G |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-23 |