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 COAXESS CATHETER SLU003 NA manufactured by Conceptus, Inc..
[75427]
During a falloposcopy procedure, the coaxess (tm) catheter perforated the uterus, approx 0. 5 to 1cm away from the tubal ostium. No med intervention was required. The event was followed by a prescheduled hysterectomy. This is an anticipated adverse event as stated in product labeling. Adverse event is marked "other" because it is unk whether or not this event may result in permanent impairment of body function or permanent damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1997-00007 |
| MDR Report Key | 129476 |
| 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 | 1997-09-01 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAXESS CATHETER |
| Generic Name | UTERINE CATHETER |
| Product Code | HGS |
| Date Received | 1997-10-31 |
| Model Number | SLU003 |
| Catalog Number | NA |
| Lot Number | C02017 |
| ID Number | NA |
| 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 | 126646 |
| Manufacturer | CONCEPTUS, INC. |
| Manufacturer Address | 1021 HOWARD AVE. SAN CARLOS CA 94070 US |
| Baseline Brand Name | COAXESS (TM) CATHETER |
| Baseline Generic Name | UTERINE CATHETER |
| Baseline Model No | SLU003 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-31 |