MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,06 report with the FDA on 1996-12-24 for ROBUST GUIDEWIRE AND VS CATHETER GUI006, VSC002 NA manufactured by Conceptus, Inc..
[36291]
The guidewire and catheter perforated the fallopian tube during a falloposcopy procedure. This is an anticipated adverse event ,as indicated in the product labeling. * the adverse event is marked "other" because it is unknwon as to whether the adverse event results in permanent impairment of body function or permanent damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1996-00006 |
| MDR Report Key | 58699 |
| Report Source | 01,02,05,06 |
| Date Received | 1996-12-24 |
| Date of Report | 1996-12-23 |
| Date of Event | 1996-01-01 |
| Date Mfgr Received | 1996-11-25 |
| Date Added to Maude | 1996-12-31 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROBUST GUIDEWIRE AND VS CATHETER |
| Generic Name | GUIDEWIRE AND CATHETER |
| Product Code | MKO |
| Date Received | 1996-12-24 |
| Model Number | GUI006, VSC002 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 59142 |
| Manufacturer | CONCEPTUS, INC. |
| Manufacturer Address | 1021 HOWARD AVE SAN CARLOS CA 94070 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-24 |