MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-07 for N/A 11165 manufactured by Ascent Halthcare Solutions.
[1491410]
It was reported that during an unknown procedure, the femostop seal was leaking and caused the patient to have a pseudo aneurysm which required a surgical resection to correct. The patient was reported to be in satisfactory condition after the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8566676]
At the time of this report the device investigation had not been completed. Once the investigation is completed, a follow-up mdr will be submitted. This is the first complaint ascent has received for a femostop causing a pseudo aneurysm.
Patient Sequence No: 1, Text Type: N, H10
[19748864]
This mdr is associated with an ascent voluntary recall for six (6) femostop lot numbers where the device may fail to inflate properly and may leak due to a seal separation between the dome and plastic arch base. On june 18th ascent initiated a voluntary recall for the six femostop lot numbers so this follow-up mdr is being filed due to the additional information obtained during the recall. The patient information was not provided to ascent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056128-2010-00011 |
| MDR Report Key | 1677121 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-07-15 |
| Date of Event | 2010-04-09 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2009-11-30 |
| Date Added to Maude | 2010-07-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT HALTHCARE SOLUTIONS |
| Manufacturer Street | 5307 GREAT OAK DRIVE |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NMF |
| Product Code | NMF |
| Date Received | 2010-05-07 |
| Returned To Mfg | 2010-04-21 |
| Model Number | 11165 |
| Catalog Number | 11165 |
| Lot Number | 880274 |
| Device Expiration Date | 2010-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HALTHCARE SOLUTIONS |
| Manufacturer Address | 5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-07 |