MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-28 for FEMOSTOP * manufactured by Ascent Healthcare Solutions.
[1500211]
Patient was post heart cath procedure and in icu for arterial line/femoral sheath removal. The rn pulled the femoral sheath with a femostop. The bulb inflated but would not hold pressure. The femostop was from lot #879762. Staff got another femostop with a lot #878439 which also failed. Finally a femostop with a different lot number was used and worked appropriately. The rn reported that another icu unit had also had a similar experience with a femostop with the lot #879762. The patient experienced minor bleeding. All the product was pulled from the shelves and is being held by materials management. ====================== health professional's impression======================the bulb would not stay inflated so would not provide the compression-assist for vascular closure. ====================== manufacturer response ======================materials management has collected the malfunctioning devices and said that they were notifying the manufacturer. Manufacturer is coming to the facility to look into the events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1673676 |
| MDR Report Key | 1673676 |
| Date Received | 2010-04-28 |
| Date of Report | 2010-04-28 |
| Date of Event | 2010-04-26 |
| Report Date | 2010-04-28 |
| Date Reported to FDA | 2010-04-28 |
| Date Added to Maude | 2010-05-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMOSTOP |
| Generic Name | CLAMP, VASCULAR, REPROCESSED |
| Product Code | NMF |
| Date Received | 2010-04-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 879762 & 878439 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 5307 GREAT OAK DR. LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-28 |