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 1996-12-23 for TROPHOCAN CVS CATHETER 4870-26 manufactured by Smiths Industries Medical Systems.
[80616]
The patient underwent the cvs procedure at 11. 4 weeks gestation. One tranacervical catheter pass was attempted, but the pass was terminated due to a subchorioic bleed; no sample was obtained. Possible spontaneous rupture of the membranes occurred 3 days post procedure. Followup ultrasound 7 days post procedure revealed no amniotic fluid. The patient underwent bed rest for one week without reaccumulation of fluid. No fetal anomalies were id. A d&c was performed on 3/14/96.
Patient Sequence No: 1, Text Type: D, B5
[7766549]
A. 4. Unk - this info is unknown because it was not recorded on the patient's chart. B. 3. Date listed is the date of the cvs procedure. B. 5. Additional details have been provided as well as a correction to the patient's gestational age at the time of the cvs procedure. Section f is not completed because this event was not reported by the initial reporter to the user facilities mdr contact person.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-1996-00095 |
| MDR Report Key | 57377 |
| Report Source | 02,05,06 |
| Date Received | 1996-12-23 |
| Date of Report | 1996-11-26 |
| Date of Event | 1996-02-28 |
| Date Mfgr Received | 1996-11-26 |
| Date Added to Maude | 1996-12-24 |
| 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 |
| Remedial Action | MA |
| 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 | 1996-12-23 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | NI |
| ID Number | NA |
| Device Expiration Date | 1997-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 57869 |
| Manufacturer | SMITHS INDUSTRIES MEDICAL SYSTEMS |
| 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 | 1996-12-23 |