FDA Adverse Event
Injury
Summary report: N
6F ANGIO-SEAL EVOLUTION
MDR report key: 2041911
·
Received March 30, 2011
Report
- Report Number
- 2182269-2011-00053
- Event Type
- Injury
- Date Received
- March 30, 2011
- Report Date
- March 30, 2011
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- MGB
- PMA / PMN Number
- P930038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE ANGIO-SEAL WAS BEING PULLED BACK, THE SUTURE BROKE. THE COLLAGEN AND SUTURE CAME OUT OF THE PT, WHILE THE ANCHOR REMAINED INSIDE THE VESSEL. MANUAL COMPRESSION WAS PERFORMED AND A PRESSURE BANDAGE WAS APPLIED TO THE PUNCTURE SITE. THE PT WAS KEPT IN THE HOSPITAL FOR A FEW DAYS AND BEING MONITORED FOR ISCHEMIA SYMPTOMS. THE PT REPORTED TO BE FINE AND WAS DISCHARGED FROM THE HOSPITAL AFTER THE MONITORING PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6F ANGIO-SEAL EVOLUTION | ANGIO-SEAL DEVICE | MGB | ST. JUDE MEDICAL | NA | 3186448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |