MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06 report with the FDA on 1997-02-12 for TROPHOCAN CVS CATHETER 4870-26 manufactured by Smiths Industries Medical Systems, Inc..
[21960796]
The pt underwent the cvs procedure at 9. 5 weeks gestation. Two transcervical passes were made. The pt reported spotting and cramping two weeks post procedure and spontaneously aborted the fetus at 11. 6 weeks gestation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-1997-00009 |
| MDR Report Key | 67972 |
| Report Source | 02,05,06 |
| Date Received | 1997-02-12 |
| Date of Report | 1997-01-13 |
| Date of Event | 1996-03-05 |
| Date Mfgr Received | 1997-01-13 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 1997-02-13 |
| 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 | TROPHOCAN CVS CATHETER |
| Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Product Code | LLX |
| Date Received | 1997-02-12 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | 508582 |
| ID Number | NA |
| Device Expiration Date | 2000-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 67979 |
| Manufacturer | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 15 KIT ST. KEENE NH 03431 US |
| Baseline Brand Name | TROPHOCAN CVS CATHETER |
| Baseline Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Baseline Model No | NA |
| Baseline Catalog No | 4870-26 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-12 |